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Careers

Project Management Analyst

AT00156
2024-02-05

• Lead complex Research and Development Innovation projects focused on digitally accelerating clinical trials and related processes to move faster in the drug development lifecycle.

• Ensure project adherence to quality standards, clinical trial regulations, and data management protocols while complying with internal procedures and SOPs to develop an integrated clinical trial solution.

• Assist the clinical study teams by introducing innovative solutions to clinical trial processes and enhancing trial site experience.

• Research and collate data to demonstrate a business case for this need and voice its economic benefits to the organization.

• Develop comprehensive project plans, defining scope, objectives, deliverables, timelines, and resource requirements, and oversee their successful execution to achieve project goals within budget and schedule constraints.

• Facilitate tactical discussions between R&D teams, business insights and analytics, clinical data management, IT, and external vendors to ensure efficient, timely, and cost-effective delivery of project milestones.

 • Create and update comprehensive Microsoft Project schedules, RAID logs, and high-level timelines for all assigned projects, ensuring effective monitoring and control of project deliverables and outcomes that align with the business priorities.

• Identify potential risks and issues that impact project outcomes, maintain a risk register, develop risk mitigation strategies, and implement measures to address challenges and minimize disruptions to project progress.

• Proactively track and monitor project progress including financials, schedule, resource constraints, risks and opportunities, contract status, and other appropriate project performance indicators.

 • Manage project budgets, track expenses, and allocate resources efficiently to optimize project delivery and ensure cost-effective utilization of resources while maintaining quality standards.

• Collaborate with other project managers and stakeholders for cadence. Lead project meetings, draft agenda and roll out minutes of the meetings to cascade key communication.

 

Qualification:

 

This position requires a minimum of a bachelor’s degree in a closely related field. 

Software Developer (Salesforce)

AT00155
2023-12-21

·       Own all technical aspects of Salesforce.com implementations and / or customizations including data migrations, data quality, systems integrations, 3rd party applications, AppExchange products, and custom development.

·       Development using Lightning flows, REST/SOAP API integrations, Apex programming, ETL integrations, and other technologies to build customized solutions that support business requirements.

·       Propose technical best practices (e.g., integration and application development, deployment, testing, iterative refinement).

·       Identify ways to utilize SFDC to improve business processes and productivity and make recommendations to support an organization scaling at a rapid pace.

·       Define, communicate, and manage a change management (release) process to develop and implement new applications/code and updates to existing applications/code.

·       Work on sprint code releases and coordinate with other teams.

·       Identification of risks and issues from a technical perspective.

·       Work on Process flow, application validations and issues.

 

Qualification:

 

This position requires a minimum of Bachelor degree in Computer Science, Information Technology or a closely related field. 

Database Administrator III

AT00154
2023-12-14

·       Design complex matrix to ensure database performance parameters are met and to design production of large database and Manage large database systems to develop the scope of projects and identifying the limitations

·       Develop large databases as per the customized needs and integrate multiple modules into a single resource

·       Manage large database systems to develop the scope of projects and identifying the limitations

·       Monitor Schema Management, Security management(users/roles), Tablespace usage, alert log, trace files, disk usage, Table/index analyze jobs, database backup logs etc. and sending status reports to higher management for review.

·       Setup Aurora Postgres, Redshift, PostgreSQL and MySQL database instance in AWS per application requirement

·       Migrate data from on-prem Oracle databases to AWS using Amazon DMS (Data Migration Service) per application team requirement

·       Design the database schema and alter as per the Relational database Management Systems applications

·       Upgrade Oracle databases, apply quarterly patches and setup database servers with 19c RAC, VCS and single node as per application needs in on-prem env.

·       Upgrade and apply latest database, OS security patches for Aurora Postgres, Redshift, PostgreSQL and MySQL database instances in cloud.

·       Work with development team on database design Data modelling, Schema design using ER Studio depending on requirements

·       Investigate cloud databases (Oracle, Postgres, Aurora Postgres, Redshift) performance related issues using cloud metrics, events and logs

·       Investigate database performance related issues using a range of tools including AWR, ASH, extended tracing & TKPROF, ADDM (Automatic Database Diagnostic Monitor) and SQL tuning advisor, Splunk and OEM (Oracle Enterprise Manager) 13c.

·       Test and approve new databases installation as per the needs and alter production databases

·       Work closely with Programmer Analysts and application developers that all database needs are met

 

Qualification:

 

This position requires a minimum of a Bachelor’s Degree in Computer Science or a closely related field.

Clinical SAS Programmer

AT00153
2023-12-18

 •Act as a Lead SAS Programmer in guiding team and doing all Project deliverables.

 •Write complex SAS programs to generate tables, listings and figures for inclusion in Clinical Study       Reports, annual safety reports, and other documents, as requested.

 •Participate in the clinical trials process by reviewing CRFs, edit check specifications, mock tables/listings/figures, etc

 •Also had experience with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.

 •Involved in creation of ADHOC reports for FDA, MAA and PMDA Submission Agencies.

 •Assist with statistical quality assurance review and program validation for each project.

 •Interact with other departments such as Statisticians, Project Management, Data Management, Clinical, Regulatory and Medical Writer teams to ensure a high level of client satisfaction through successful execution of projects.

 

Qualification:

 

This position requires a minimum of a Bachelor’s Degree in Statistics, Computer Science, Information Technology, Management Information Systems or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.

Angular Developer

AT00152
2023-12-07

• Coordinate with product development and Business analyst teams and developing code to support new application features.

 • Participate in system design specification session to document technical specifications and to provide design options and solutions.

 • Write DOTNET and Angular Code for maintain the application using technical specifications to update existing application and/or to develop new application.

 • Utilize programming principles, tools like SSIS/SSRS and techniques to application codes.

 • Apply analytical, technical skills like C#, SQL Server and other programmatic skills to resolve application related issues.

 • Provide coding effort in JIRA tool to track time and budget to project manager.

• Develop applications according to company’s software development life cycle (SDLC) methodology.

• Ensure that builds are properly deployed in development, system, acceptance, and production environments.

 • Prepare test cases and strategies for unit testing and integration testing.

• Provide technical and functional support to testing teams.

 • Assist technical writers in preparing project documentation.

 

Qualification:

 

This position requires a minimum of a bachelor’s degree in Computer Science or a closely related field.

Equipment Validation Engineer

AT00151
2023-12-22

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00150
2023-12-22

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00149
2023-12-21

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00148
2023-12-21

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00147
2023-12-20

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00146
2023-12-20

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00145
2023-12-19

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00144
2023-12-19

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00143
2023-12-18

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00142
2023-12-18

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00141
2023-12-15

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00140
2023-12-15

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00139
2023-12-14

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00138
2023-12-14

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00137
2023-12-13

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00136
2023-12-13

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00135
2023-12-12

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00134
2023-12-12

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00132
2023-12-11

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00131
2023-12-11

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00130
2023-12-08

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00129
2023-12-08

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00128
2023-12-07

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00127
2023-12-07

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00126
2023-12-06

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00125
2023-12-06

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00124
2023-12-05

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00123
2023-12-05

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00122
2023-12-04

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00121
2023-12-04

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00120
2023-12-01

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00119
2023-12-01

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00118
2023-11-30

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00117
2023-11-30

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00116
2023-11-29

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00115
2023-11-29

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00114
2023-11-28

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00113
2023-11-28

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00112
2023-11-27

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00111
2023-11-27

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00110
2023-11-24

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00109
2023-11-24

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00108
2023-11-23

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00107
2023-11-23

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00106
2023-11-22

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00105
2023-11-22

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Analyst

AT00104
2023-11-21

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT00103
2023-11-21

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Programmer Analyst

AT00102
2023-11-21

· Design both logical and physical database model in Oracle and SQL server.

· Tune SQL queries, scripts and troubleshoots issues using SQL, PL/SQL scripts.

· Integrate software components into a fully functional software system.

· Develop prototypes, mockup for users review and approval.

· Support new and existing development projects with data and process modeling activities.

· Provide entity, logical and physical data models.

· Perform database design across multiple platforms.

· Provide technical guidance to the application development team.

· Collaborate with stakeholder to ensure application architecture is in alignment with business requirement.

· Ensure logical flow of the system requirements to flowcharts, screen layouts and documentation.

· Fine-tune data model to achieve consistent performance.

· Work on metadata management, data modeling, Erwin or ER Studio and related tools.

 

Qualification:

 

This position requires a minimum of a bachelor’s degree in computer science, computer information systems, information technology, or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.

Informatica Developer

AT00101
2023-09-18

·       Involve in gathering specific requirements, analysis and design to develop & implement new complex functionality.

·       Active involvement in all the phases of the software development life cycle such as data analysis, complex database design, development, performance tuning, integration, implementation and support for databases in Client enterprise environments.

·       Extensive working on PowerCenter 9.6.1 and 10.2 Source Qualifier Transformation to join the homogeneous sources.

·       Work on specialized Informatica PowerExchange 9.6 for Loading/Retrieving data from mainframe systems.

·       Work with various large Databases for extracting the files and loading them into different databases.

·       Use Teradata database, analyzing complex business needs of clients, developing effective and efficient solutions and ensuring client deliverables with in committed timelines.

·       Work on designing the ETLs on PowerCenter and conducting review meets.

·       Use GITEye to baseline code/files for deploying in higher environments.

·       Work on Incremental Loading using Parameter Files, Mapping Variables, and Mapping Parameters.

·       Unix Shell Scripts for executing the Informatica workflows.

·       Use various mappings to load data from various sources using different Transformations including Router, Aggregator, Joiner, Lookup, Update Strategy, Stored Procedure, Sorter, Filter, Source Qualifier, Expression, Union and Sequence Generator to store the data in target tables.

·       Involve in specific Unit Testing, Integration Testing and End-End Testing.

·       Provide technical support to SIT, UAT and PROD users and testers.

·       Analyze the root cause and fixing production issues and Support the Client Production Environments a first priority.  

Qualification:

This position requires a minimum of a bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses

Validation Analyst

AT00100
2023-11-20

JOB ID 10822: Validation Analyst

 

Aplomb Technologies Inc., a Princeton, NJ-based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10822: Validation Analyst.

Job duties include:

 

l  Participating in "Release to Manufacturing" efforts to ensure that lab instruments and equipment are properly validated and qualified before being used in production.

l  Managing the documents required for the validation and qualification of lab instruments and equipment, ensuring compliance with relevant regulations and guidelines.

l  Creating and reviewing all validation documents for the project, such as validation plans, training plans, issues logs, design reviews, IQ/OQ/PQ protocols and reports, test cases, trace matrices, change controls, and validation reports.

l  Performing equipment and IT validation activities, including developing user and system requirements, evaluating risks associated with the user requirements, and developing appropriate remediation and test strategies.

l  Developing test strategies and plans for the execution of operational and performance protocols.

l  Developing defect reports, and tracking them for resolution, and preparing validation summary reports to summarize all the test activities, including any open deviations.

l  Performing Root Cause Analysis (RCA) for defects observed during testing and performing Corrective Action  Preventive Action (CAPA) for deviations observed during the execution of validation protocols.

l  Gathering CSV metrics for reporting purposes, tracking and monitoring review and approval of validation deliverables, and participating in meetings with project teams and client stakeholders as required.

l  Participating in internal or external training programs to maintain knowledge of validation principles, and stay up-to-date with the latest regulations and industry trends.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related with at least 6 months of experience. Salary ranges between $81,557 to $83,000/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Equipment Validation Engineer

AT0099
2023-11-20

JOB ID 10827:  Equipment Validation Engineer

APLOMB TECHNOLOGIES INC, a Princeton, NJ based IT and Life Sciences Consulting Services Firm has multiple openings for JOB ID 10827:  Equipment Validation Engineer.

Job duties include:

 

·        Involve in creating validation documents such as plans, requirements, protocols, test scripts, and reports for GxP and non-GxP systems according to Good Automated Manufacturing Practices

·        Able to Conduct installation qualification on equipment by checking engineering drawings, P, and system build, and ensuring critical requirements are met.

·        Preparing, maintaining, validating, and compliance documents such as engineering change controls, schematics, and protocols

·        Conducting validation or qualification tests of new or existing equipment, following company protocols and external standards

·        Develop strategies and support validation projects that comply with the electronic record.

·        Investigating, and resolving complex issues, implementing corrective and preventative actions for clients, and supporting Root Cause Analysis of deviations.

·        Conducting strength tests on sutures, foils, and breathers using Instron tensile testers, force gauges, and burst testers in accordance with standard operating procedures.

·        Verifying proper calibration and parameter settings for testing equipment and recording results in computer systems and device history folders

·        Work closely with the team in Collaborating on processes and Collecting data for quality improvement.

 

Requirements: Master's degree in Mechanical Engg, Manufacturing Engg, Ind Engg or related. Salary ranges between $81,557.00 to $83,000.00/year. Send resume to: moushmi.s@aplombtek.com including the JOB ID. Travel and relocation to various unanticipated client locations throughout the United States may be required. Equal Opportunity Employer.

Validation Specialist

AT0097
2023-10-09

·       Perform Validation Assessment on customized and off-the-shelf clinical trial data processing systems in compliance with the applicable FDA Regulations that are 21CFRPart11 and 21CFRPart820.

·       Perform GxP Functional Risk Assessment on customized clinical trial applications.

·       Author System Design and Master Validation Plan documents for the customized applications.

·       Author User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)/ User Acceptance Testing (UAT), Traceability Matrix, Deviation/ Exception reports and Validation Summary Report (VSR) documents for the customized and off-the-shelf systems using a Validation Lifecycle Management System (VLMS) software.

·       Periodic Review and Audit Trail/ Data Integrity Review of different customized and third-party systems to analyze any gaps or non-compliance with the regulations and standard operating procedures.

·       Perform Root Cause Analysis for Quality incidents and involved in the preparation of CAPA (Corrective Action and Preventive Action) reports to ensure compliance with established procedure.

·       Create Test Plans and perform functional and regression testing during various phases of test lifecycle throughout the Defect Tracking and Resolution cycles.

·       Implement automation testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery.

·       Follow GAMP5 practices for authoring and reviewing Validation Documentation.

·       Support product innovation by developing novel and creative software validation processes in an Agile environment.

Qualification:

This position requires a minimum of a Bachelor’s degree in Pharmaceutical Science or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.

QlikView Consultant

AT0096
2023-09-11

        Gathering, analyzing, coordinating with different teams, and documenting QlikView/Power BI requirements. Perform Gap/ Impact Analysis, Create Test Plans/Test cases.

        Designing, developing, and testing the implementation of QlikView /Power BI reports and deploy them to QlikView Access point/ Power BI workspaces on Power BI services. Test the dashboards for product functionality- Perform unit, integration, and system testing, Research problems discovered during QA testing or product support and provide acceptable problem resolutions by debugging and modifying code and supporting user needs. Also, communicate with the end users for verifications of solutions provided.

        Provide on- going support in maintenance of QlikView/Power BI files and while working with other teams- Infrastructure, Application Development and External QlikView consultants during the QlikView version upgrade projects.

        Creating Tidal jobs for scheduling the QlikView/Power BI reports by creating batch files and monitor them during the Daily, Monthly and Quarterly cycles.

        Creating Power Automate reports and printing reports for weekly and monthly distribution to different teams.

        Participate in code reviews and design meetings.

        Assigning and maintaining QlikView/Power BI licenses to the users.

        Design and develop database tables, views for QlikView using Oracle- Toad for Oracle 12.8, Microsoft SQL Server database- Toad for SQL Server 6.7v. And create connections between database and QlikView, Create Gateway connections between databases and Power BI.

        Create and maintain QlikView training manuals/documentation. Conduct Training sessions for QlikView users who are new to the organization, Conduct QlikView Knowledge Transfer/ Training sessions -to New QlikView consultant(s) joining the Team. Also, Assist Team members with QlikView related questions on their projects.

        Work on migrating the Business Objects reports from development to production using promotion management tool from the Central Management Console.

        Create Informatica Mapping, Workflow using PowerCenter Designer, PowerCenter Workflow Manager. And schedule the workflows for saving the time of updating the tables and monitor the workflows using PowerCenter Workflow Monitor.

        Participate in the Disaster Recovery drill performed by the Infrastructure and Datawarehouse team.

 

Qualification:

 

This position requires a minimum of a Bachelor’s Degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects. 

Regulatory Affairs Associate

AT0095
2023-08-15

·       Perform different submissions for IND, NDA, BLA, DSURs, Agency Meetings, health Authority     meetings and CMC amendments for all Oncology products.

·       Responsible to be part of meeting discussions at onsite, and coordinate with Global regulatory  strategists, publishing team (Submission specialist) and CMC team to be submitted in timely manner.

·       Plan and coordinate all the submissions for IND, NDA, BLA, DSURs, Annual Reports, Safety reports.

·       Part of Meeting discussions at Onsite with client.

·       Perform the quality checks and submit in the ECTD format for the dossiers being submitted to FDA.

·       Coordinate with Global regulatory strategists, publishing team (Submission specialist) and CMC team, SME so that the filings or submissions could be dispatched in timely manner.

·       Once the labeling and annual reports are submitted to Division, the status should be marked as  submitted and submitted date should be provided to be compliant with the annual reports and labeling submissions.

·       Perform archiving the complete submission with their Sequence numbers in Contact Database for  ongoing purpose.

·       Arrange meetings with the GRS and Clinical developments team to ensure the IB and Annual  reports are submitted with due diligence and provide the template to the team.

·       Prepare the cover letter and FDA forms for all different submissions and sign them to import to the Virtual document.

 

Qualification:

 

This position requires a minimum of a Bachelor’s degree in Biomedical Engineering, or administration with a concentration in management, business or related or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.  

Regulatory Affairs Specialist

AT0094
2023-08-07

Independent Laboratory Work and Data Analysis:

-        Plan, execute, and oversee laboratory experiments related to medical device labeling and performance characterization.

-        Collect accurate and reliable data, meticulously recording experimental procedures, observations, and outcomes.

-        Perform thorough data analysis using appropriate statistical methods and software tools to derive meaningful insights.

 

Design and Build Laboratory Test Fixtures:

-        Conceptualize, design, and construct test fixtures and setups for medical device experiments, ensuring accuracy and reproducibility.

-        Collaborate with cross-functional teams to identify specific requirements and develop tailored solutions.

-        Troubleshoot Experiments and Instrumentation:

-        Identify and address issues that arise during experiments, instrumentation setup, or data collection.

-        Apply problem-solving skills to diagnose and resolve technical challenges promptly and effectively.

 

Learning New Experimental Techniques:

-        Stay current with advancements in experimental techniques, equipment, and methodologies relevant to medical device performance evaluation and labeling.

-        Actively seeking opportunities to learn and integrate new techniques.

 

Demonstration of Skill and Protocol Modification:

-        Showcase proficiency in a diverse range of experimental techniques and adapt protocols as needed to meet specific project requirements.

-        Collaborate with team members to optimize protocols for improved accuracy and efficiency.

-        Scientific Context and Literature Review:

-        Contextualize experimental findings by consulting scientific literature, citing relevant studies, and positioning your results within the broader scientific framework.

-        Contribute to the development of comprehensive reports and presentations that effectively communicate the significance of your work.

-        Technical Proficiency in Medical Device Performance Characterization:

-        Apply technical expertise to assess and characterize the performance of medical devices, including functionality, safety, and reliability.

-        Adherence to Corporate Standards and Compliance:

-        Understand and adhere to corporate standards, code of conduct, safety protocols, medical device design controls, and relevant compliance standards (such as GxP regulations).

 

Qualification:

 

This position requires a minimum of a Bachelor’s degree or its equivalent in Life Sciences or a closely related field.

Software Developer

AT0093
2023-07-20

·       Review requirements and design documents with business analysts, developers, and project managers to confirm expected functionality with business needs.

·       Develop Complex SQL Queries in Teradata, Oracle, etc.

·       Develop Terraform Code to Build and Maintain Infrastructure in Azure.

·       Develop Pipelines in git hub using Git Actions, to deploy the code into higher environments.

·       Develop Pipelines to train and retrain the ML models, deploy them to higher environments.

·       Design, engineer and develop information technology solutions using informatica, Synapse & ADF.

·       Design, deploy data integration solutions in a test data ware housing involving complex data transformation, change and error handling using unit and integration testing, database testing.

·       Implementation, evaluation and documentation of the developed test cases and test scenarios.

·       Validation and development of data warehouse data, using complex SQL Queries in Teradata, oracle, etc. to perform data analysis and apply problem solving skills to explain why actual results do not match expected results.

·       Validation of List reports, Drill Down reports, Drill through reports, cross tab reports in Tableau, Power Bl, SAP BO using SQL queries in Azure, Teradata, oracle, etc. and business requirements.

·       Develop SQL Queries in Azure, Teradata, oracle, etc. to analyze data to prepare test cases that will accurately verify the data.

·       Participate in project meetings/ design groups as a team member with other data analysts to design, engineer and develop test solutions.

·       Design documents to build ETL maps to test the migration.

·       Build manual and automated Scripts in Python.

·       Build Complex, Sub Queries to compare the data between different source systems and the target systems using DB.

·       Review the test results with the leads of the project and explaining all the conditions how the data has been populated in t he target tables or the extracts.

 

Qualification:

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to a related degree.

Equipment Validation Engineer

AT0091
2023-06-22

·       Author and revised system life cycle deliverables, including Impact Assessment, Data Integrity Assessment, User Requirement Specification, Validation Plan, Commissioning Plan, Installation/Operational/Performance Qualification Protocols, Trace Matrix, and Validation Summary Report, following client procedures and Good Automated Manufacturing Practices.

·       Conduct validation testing of new or existing equipment, in accordance with company protocols and external regulatory standards.

·       Perform Installation qualification on the assets by verifying engineering drawings, schematics, system build, and ensuring minimum requirements are met.

·        Conduct risk assessments and accordingly developed validation strategies for new, proposed, or modified systems.

·       Assess client systems and identified any potential Part 11 gaps to ensure data integrity best practices are enforced.

·       Work closely with Engineering / Facilities, Equipment End Users, and Quality Assurance to investigate and resolve non-conformances encountered during qualification activities.

·       Prepare, maintained, or reviewed validation and compliance documentation, such as engineering change controls, schematics, and protocols.

·       Ensure completeness of testing via the development of traceability matrices that mapped requirements to testing.

·       Evaluate equipment related deviations, discrepancies, non-conformances, and change control for completeness and impact on process/product.

Qualification:

This position requires a minimum of a Bachelor’s degree in mechanical engineering or a closely related field.

Software Developer

AT0090
2023-06-19

·        Contribute and maintain a UI framework, by working with designers and developers.

·        Implement reusable, testable, and accessible UI components, based on modern web tools and technologies.

·        Work with developers from other teams, to help them use the library in their applications.

·        Participate in architectural strategies, from PoC, proposal to implementation Modernize the library with latest tools and technologies.

·        Design, develop, document, test, and debug new and existing software.

·        Use the ReactJS framework, which involves creating various components and integrate these components to build the complete user interface.

·        Develop custom solutions within an existing application framework. Demonstrate the ability to code, test, and document and deploy a solution.

·        Contribute to all phases of the software development lifecycle using best practices in object-oriented techniques.

·        Write test reports and conduct testing when necessary. Testing the product in controlled, real situations before going live.

·        Participate in software design meetings and analyze user needs to determine technical requirements.

·        Troubleshoot, debug, and upgrade existing software.

Qualification:

This position requires a minimum of a Bachelor’s Degree or its equivalent in Computer Science or a closely related field.

Clinical SAS Programmer

AT0089
2023-06-29

·        Act as a Lead SAS Programmer in guiding team and doing all Project deliverables.
·        Involved in creation of ADHOC reports for FDA, MAA and PMDA Submission Agencies.
·        Write complex SAS programs to generate tables, listings, and figures for inclusion in Clinical Study Reports, annual safety reports, and other documents, as requested.
·        Participate in the clinical trials process by reviewing CRFs, edit check specifications, mock tables/listings/figures, etc.
·        Also had experience with drug development life cycle and experience with the manipulation, analysis and reporting of clinical trials data.
·        Assist with statistical quality assurance review and program validation for each project. 
·        Interact with other departments such as Statisticians, Project Management, Data Management, Clinical, Regulatory and Medical Writer teams to ensure a high level of client satisfaction through successful execution of projects.


Qualification:

This position requires a minimum of a Bachelor’s Degree in Statistics, Computer Science, Information Technology, Management Information Systems, or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects. 

Validation Analyst

AT0088
2023-06-02

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

Validation Analyst

AT0087
2023-06-02

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0086
2023-06-02

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0085
2023-06-02

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0084
2023-06-02

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0082
2023-06-01

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0081
2023-06-01

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0080
2023-06-01

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0079
2023-06-01

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0077
2023-06-01

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0075
2023-05-31

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0074
2023-05-31

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0073
2023-05-31

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0072
2023-05-31

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0071
2023-05-31

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0069
2023-05-30

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0068
2023-05-30

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0067
2023-05-30

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0066
2023-05-30

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0065
2023-05-30

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0063
2023-05-29

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0062
2023-05-29

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0061
2023-05-29

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0060
2023-05-29

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0059
2023-05-29

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0057
2023-05-26

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0056
2023-05-26

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0055
2023-05-26

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0054
2023-05-26

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0053
2023-05-26

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0051
2023-05-25

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0050
2023-05-25

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0049
2023-05-25

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0048
2023-05-25

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0047
2023-05-25

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Validation Analyst

AT0045
2023-05-24

       Validation Analysts:            Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $87,422/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 1 yr as SAS Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


Validation Analyst

AT0044
2023-05-24

Validation Analysts:           Review documents including clinical study reports, labeling drafts and validation and stability protocols and reports. Develop and Execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Perform GAP analysis on GXP system that directly affects product quality and Data Integrity and ensure all the requirements have been tested and also comply with applicable FDA Regulations. Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical production. Prepare and submit of Chemistry, Manufacturing, and Controls (CMC) sections for regulatory drugs and submissions, information amendments, supplements, and annual reports. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $71,219/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Pharmacy/Chemistry/Regulatory Affairs or related + 2 yrs as Clinical Data Analyst, Regulatory Affairs Associate, QA Analyst or related, processing PMA Submission and using clinical data management systems, software validation life cycle, Test Plan, EDC applications (Medrio, Inform, RAVE), or SAS Programming.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540         

 

Contact:                              Moushmi Saha, HR Manager

Aplomb Technologies, Inc.

careers@aplombtek.com

101 College Road East, Suite 301 

Princeton, NJ 08540


Software Developer

AT0043
2023-05-24

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using using DotNet, MVC, C#, SSIS/SSRS, Power BI, SQL Server, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540

     

Software Developer

AT0042
2023-05-24

 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $85,197/year    

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    BS or foreign equivalent in Comp. Sc./IT or related + 2 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540                                          

Software Developer

AT0041
2023-05-24


 Software Developers:         Analyze user business needs and software requirements. Design, develop and modify applications and systems software using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA. Coordinate software system installation and functionality. Develop software application and system testing and validity procedures and documentation. Perform software integration and testing, and develop enhancements, modifications/debugging and develop custom components; and coordinate user training and technical documentation as needed. Travel to various unanticipated locations in the United States to interact with clients and train end users for short or long term assignments

 

Salary:                                $133,390/year  

 

Work Schedule:                  8:30 am-5:30pm; 40 Hrs/week (M-F)

 

Requirements:                    MS or foreign equivalent in Comp. Sc./IT/MBA with Comp Sc as major or minor/ or related + 1 yr of relevant IT experience using Java, ETL, PL/SQL, Oracle DB, Java Script, and JIRA.

 

Job Location:                      101 College Road East, Suite 301, Princeton, NJ 08540  

 

Contact:                              Moushmi Saha, HR Manager    

                                           Aplomb Technologies, Inc.

                                           careers@aplombtek.com

101 College Road East, Suite 301

Princeton, NJ 08540


  

Software Engineer

AT0039
2022-03-14

·        Work on analyzing business requirements and architecting a solution that is robust and scalable along with providing technical documentation of the solution.

·        Write well-designed, testable code and leverage new technologies to build the next generation of core framework services.

·        Develop and deliver new features every few days.

·        Work in application development frameworks like Vertx, Spring, etc., and Asynchronous programming.

·        Develop unit test plans and automated tests that ensure stable releases and improved product stability.

·        Work on debugging coding issues and implementing feedback from team members to update code and create new models.

·        Implement CD pipelines invoking Jenkins and GIT to complete the automation from commit to deploy.

·        Analyze customer queries and technical issues to identify software bugs and produce innovative solutions to reduce troubleshooting times.

·        Participate in Improving software performance and quality standards by regularly maintaining and updating existing codebases.

 

Qualification:

 

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to a related degree. 

Software Developer

AT0038
2023-05-15

·       Involved in SDLC phases like Requirement gathering, Analysis and code development.

·       Develop code and execute data scripts for programming, testing and validating the system software.

·       Assist in building new software as per business needs.

·       Create Stored Procedures for the software code needed using Microsoft BI and SQL programming.

·       Design, develop and modify the existing code to enhance the system performance using Agile SCRUM Methodology.

·       Participate in sprint planning to develop code as per new business requirement.

·       Assist in the construction, testing and validation of automated and on-demand reports.

·       Create different Power BI reports utilizing the desktop and the online service and schedule    refresh.

·       Design and implement end-to-end data solutions (storage, integration, processing & visualization).

·       Scheduling the Automated jobs using SQL Server Job Agent.

·       Day-to-day deliverables using SQL and related programming language code for unit testing, agile development user stories, SSIS and SSRS packages.

·       Develop automated Reports using SSRS.

·       Performing extraction, transformation and loading (ETL) operations.

·       Document the data mapping documents and the data cleansing reports coordinating with

business team and application deployment teams.

·       Store and maintain version control of the code for data analysis using TFS and Microsoft

Visual Studio.

·       Work with the Analyst team to gather the business requirements and develop software to meet those needs.

 

Qualification:

 

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to a related degree. 

DevOps Engineer

AT0037
2023-05-15

·       Creating, Managing & Supporting AWS Cloud Infrastructure for Applications teams working in production & non-production environment.

·       Performing Application Code deployment in different environments using tools such as GitHub, Jenkins, EC2, EMR, ECS, S3 (AWS services).

·       Rehydrating Infrastructure with latest Amazon Machine Image (AMI) for RedHat and Amazon Linux Operating System on a bi-weekly basis.

·       Troubleshooting Dev, QA, Prod-Stage, Prod Environment Issues with respect to running AWS Services in our framework.

·       Infrastructure Inventory Management in RDS Postgres Database using python script, for capturing AWS services information with respect to our business units.

·       Actively Monitoring AWS Infrastructure and running services using Prometheus and Grafana for effective data collection and Visualization.

·       Supporting Incidents/Issues in Production environment using PagerDuty Alert Notification System.

·       Maintaining up to date documentation and ensuring all the services are in compliance with respect to the company’s policy and guidelines.

·       Identifying production issues and implementing integrations that meet customer needs.

·       Deploy and operate different systems and applications in Cloud.

·       Automate and streamline integration and deployment operations and processes.

·       Work with application teams to oversee the code and infrastructure as code releases.

 

 

Qualification:

 

This position requires a minimum of a Bachelor’s Degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.       

Project Management Analyst

AT0036
2023-05-18

·       Create and maintain project scope, project plan, timelines, budgets, teams, and project objectives/goals for complex and/or high priority assets in the pharmaceutical development portfolio.

·       Ensure risk management plan is active and routinely discussed in the project matrix team to assess, capture, and design mitigation steps.

·       Proactively track and monitor project progress including financials, schedule, resource constraints, risks and opportunities, contract status, and other appropriate project performance indicators.

·       Prepare and deliver presentations to all levels of the organization which may include technical and budgetary information.

·       Facilitate strategic and tactical discussions between R&D teams, manufacturing, and product development teams, and support decision making by providing necessary data.

·       Facilitate project meetings (to include minutes) and cascade key communications.

·       Identify and assess risks associated with critical path activities and collaborate with functional leaders to support mitigation and resolution efforts.

·       Lead collaborative alignment efforts with technical (process, product, analytical) development, production, quality, and regulatory stakeholders.

·       Ensures efficient, timely, and cost-effective delivery of project milestones through effective planning and the identification of issues and opportunities in the project plans.

·       Conducts periodic health checks of the project plans to ensure quality of planning and control.

 

Qualification:

This position requires a minimum of a Bachelor’s degree or its equivalent experience in a closely related field.

Business Analyst

AT0034
2023-05-08

·       Plan, Design and carry out various Management related tasks as part of Development and implementation team to enable smooth, correct, and efficient workflow between various TPA and us.

·       Work with different healthcare admin systems requiring healthcare, biomedical, Design and production.

·       Carry out designing, analysis and testing of various reference management changes as a part of enhancement and implementation of new systems in the project.

·       Generate and own data artifacts like Data Requirement templates and mapping documents, converting simple business requirements into technical details that programmers can work on.

·       Co-ordinate project related efforts between various stakeholders and communicate complex technical ideas and solutions in a clear and concise manner understandable by all stakeholders.

·       Work on client data architecture, technical and non-technical processes and workflows and business domain through project work and courses in graduate program.

·       Creating prototypes, data analysis, performing business & technical calculations using wide range of tools.

·       Responsible for product design, development, improvement, analysis, reporting in terms of software data, SQL, reports.

·       Identifying project scope, requirements, budget, feature dependencies, risks etc.

·       Development of strategic plans to manage triple constraints, mitigating risks, etc.

 

 

Qualification:

This position requires a minimum of a bachelor’s degree or its equivalent experience in a closely related field. 

Clinical SAS Programmer

AT0033
2023-04-03


·        Provide validation services to client pertaining to drug development life cycle and manipulation, analysis and reporting of clinical trials data and Participate in the clinical trials process by reviewing CRFs, edit check specifications, mock tables/listings/figures.

o   Review the reports consisting of Tables, Listings and Graphs that are generated from the available databases.

o   Ensure Laboratory normal ranges are received and units are appropriate for the laboratory tests done as per standard operating procedures (SOPs).

·        Generate tables, listings and figures for inclusion in Clinical Study Reports, annual safety reports, and other documents, as requested.

o   Review and validate reports (Tables, Figures, Listings and Datasets) generated by others to support the reporting and analysis of clinical trial data.

o   Support reporting processes for collected clinical trial data for submission (NDA/BLA/IND, etc.) to Regulatory Authorities (FDA, EMEA, etc.) as per FDA regulations and ICH guidelines.

·        Identify data issues and report findings to the appropriate team members.

              o   Confirm appropriate Laboratory analytical method is used to perform the test.

              o   Understand the Laboratory data (Chemistry, Hematology, Microbiology and Urinalysis) and Pharmacology data to identify data issues, to ensure further data analysis and reporting by other line functions.

              o   Conduct analysis of the Pharmaceutical, Biochemistry and Laboratory data by various analytical methods using the provided software (e.g. Statistical Analysis System/SAS software).        

              o   Analyze the data and communicate with the Data Management / Analytical Laboratory personnel for resolving any outlier data, data issues and data discrepancies found.

·        Create SDTM and ADaM datasets based on CDSIC standards.        

              o   Review and maintain Datasets as per the CDISC (SDTM and ADaM) standards.

·        Participate in TLFs validation.

 

Qualification:

This position requires a minimum of a Bachelor’s degree in Statistics or a related science field (i.e. Pharmacy/Pharmaceutical Sciences), or a combination of education and experience equating to the U.S. equivalent in aforementioned subjects.

Software Developer

AT0026
2023-03-27

·        Use Spring Boot, Spring Cloud, Spring AOP, and Dependency Injection to create microservices.

·        Implement OAUTH 2 in order to securely communicate with other protected resources by using access token exchanges as opposed to basic authentication.

·        Create Java API for managing AWS services using Amazon Lambda and used multiple EC2 instances in an AWS cloud environment.

·        Using HTML, CSS, JavaScript, Angular 7, Angular Material, and Bootstrap, design and improve the user interface screens.

·        Developing Java Web services using REST, SOAP, WSDL, XML, and JSON and work on Service Oriented Architecture (SOA).

·        Participates in all stages of the Scrum/Kanban and Software Development Life Cycle (SDLC) processes.

·        Apply Spring Boot framework to REST Microservices implementation. Utilizing Spring AOP and Spring Actuator, generate metrics with method-level granularity and persistence.

·        To increase the coverage, create JUnit tests and use Easy Mock framework, Shell scripts for the FTP to transfer from one system to another system.

·        Work on implementing stored procedures in the application while creating tables in the Oracle 12c database.

·        Manage Docker orchestration and containerization using Kubernetes while working with DevOps techniques.

·        Using SQL and PL/SQL, created database objects such as functions, stored procedures, and triggers. Involve in the integration of the application's various layers.

 

Qualification:

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects.  

Validation Engineer

AT0025
2023-03-09

·       Provide validation expertise to develop and coordinate deliverables to validate laboratory equipment and computerized systems for regulated use while ensuring compliance with internal procedures and industry guidelines (e.g. 21-CFR-11, GAMP V, USP-1058, NIST, GCP, GLP and GxP).

·       Development and execution of Laboratory Equipment Validation Protocols.

·       Responsible of Technical Documentation, Risk Assessments, Analytical Instruments Qualification, Computer System Validation, Traceability Matrix, Validation Report, Operational and Administrative SOPs.

·       Execution of related validation protocols and documentation packages for all activities, including: Original format documents, approved document and applicable drawings.

·       Establish system boundaries, scope of work, and commissioning execution plans during Validation Life Cycle.

·       Documenting Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), traceability matrices (RTM), deviation forms and validation summary reports (VSR) documents using standard templates.

·       Author and Executing of all Policies, Procedures, Test Methods, Specifications, Validation Documents, forms, and all other documents that pertain to the production, engineering, and maintenance systems.

·       Ensured all the URS are addressed appropriately in the Requirement Traceability Matrix (RTM)

·       Review and approve validation documentation such as Standard Operating Procedures, Validation Protocols (Installation Qualification, Operational Qualification, and Performance Qualification) that are compliant to FDA and Code of Federal Regulations (CFR).

·       Provide task status and escalations in weekly cross functional team project management meetings.

·       Maintain regular project status check-ins with manager and determine task allocation amongst quality team members.

 

 

Qualification:

 

This position requires a minimum of a bachelor’s degree in Pharmacy, Chemical Engineering, or a closely related field.  

Angular Developer

AT0024
2023-03-27

·       Coordinate with product development and Business analyst teams and developing code to support new application features.

·       Participate in system design specification session to document technical specifications and to provide design options and solutions.

·       Write DOTNET and MVC Code for maintain the application using technical specifications to update existing application and/or to develop new application.

·       Utilize programming principles, tools like SSIS/SSRS and techniques to application codes.

·       Apply analytical, technical skills like C#, SQL Server and other programmatic skills to resolve application related issues.

·       Provide coding effort in JIRA tool to track time and budget to project manager.

·       Develop applications according to company’s software development life cycle (SDLC) methodology.

·       Ensure that builds are properly deployed in development, system, acceptance, and production environments.

·       Review codes to identify any basic errors.

·       Prepare test cases and strategies for unit testing and integration testing.

·       Provide technical and functional support to testing teams.

·       Assist technical writers in preparing project documentation.

 

 

Qualification:  This position requires a minimum of a Bachelor’s Degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a bachelor’s degree in one of the aforementioned subjects. 

Validation Analyst

AT0023
2023-02-13

·       Develop, review, and approve validation policies, procedures, plans and protocols for the implementation of GxP procedures for the infrastructure and computer systems

·       Analyze and test the 21 CFR Part 11 compliance tracking applications that are designed to track down the applications currently being used to comply with FDA regulations and GAMP

·       Establishment of key deliverables of computer and automated validation; User Requirement Specifications (URS), Functional Requirement Specifications (FRS), GxP Risk Assessment (RA), IQ/OQ/PQ Test Scripts, Requirement Traceability Matrix (RTM), Validation Summary Report (VSR)

·       Develop Validation and Test Plans, specifications, supplier assessment and compilation of the data and results into final reports

·       Implement formal testing of GxP computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery

·       Focus on problem identification and involved in processing of CAPA (Corrective Action and Preventive Action) reports to ensure compliance with established procedure

·       Review and approval of the change request documentation which will be created as part of the regular Operational and Support of the systems

·       Making sure that all the project teams follow SDLC SOP and create appropriate SDLC deliverables that will be approved and stored in LEADs (document management system)

 

 

Qualification:

 

A bachelor’s degree in Pharmaceutical Science or a closely related field or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned subjects.  

Oracle EBS Consultant

AT0020
2023-02-13

·       Production support on R12 General Ledger, Accounts Payables, Financial Accounting Hub, Cash Management, Fixed Assets, iProcurement, Purchasing, AME workflows etc.

·       Assist the business in month-end closing process such as reports for consolidation, trial balances, period closing, GL closing, reporting currency ledgers, etc.

·       Work on iProcurement implementation for other functional areas.

·       Configure Invoice Workflow approval process for PO matched and non-PO invoices.

·       Assist business users in issues with data flow into Oracle EBS from source systems such as Ensura, ServiceBench, Wennsoft and UltiPro through FTP process.

·       Solve various Oracle issues reported by business users through Remedy Console ticketing tool

·       Work on Oracle SRs and RFCs as an Oracle On Demand customer through Oracle. Managed Cloud Services incorporating the changes required.

·       Create, maintain and update user documents and SOPs (user manuals, quick reference guides) to help business users accomplish their tasks.

·       Analyze business requirements for enhancements and customizations, design and develop a process.

·       Involve in system administrator activities such as user setups, defining responsibilities, value sets, Flexfields, data groups, request groups, lookups, registering applications, reports etc.

·       Knowledge of SQL developer and SQL queries & procedures to understand and analyze the issues and generate ad-hoc data extracts.

·       Integrate legacy systems into Oracle EBS for acquired companies.

·       Work on various set ups and creations of test data in system and configurations in modules like GL, AP, CE, FA and Purchasing.

·       Involve in requirements gathering, analysis, development, QA and post-production support and warranty.


Qualification:


This position requires a minimum of a Bachelor's Degree in Computer Science, Computer Information Systems, Information Technology, or a combination of education and experience equating to the U.S. equivalent of a Bachelor's Degree in one of the aforementioned subjects.  

 


Validation Engineer

AT0018
2022-12-27

·       Assist in updating the implementation lifecycle documents (i.e., Business Process Documents, Configuration Design Specification, Technical and Functional Design Specification).

·       Create /Review software validation plans, Qualifications test protocols, traceability matrices, reports and all software deliverables within the scope of validation.

·       Assisting with the verification, validation and debugging of software applications.

·       Participates in root cause analysis for problem solving. 

·       Support release management activities by reviewing and ensuring the pre-requisites are release prior to the release.

·       Develop and maintain test plans, test scripts and user acceptance tests and manage the execution of test plans.

·       Perform risk assessment document using risk assessment and identify the gaps and risk factors and risk mitigation plans of the system preparing of function and configuration.

·       Coordinate with cross-functional team for post approval of qualification protocols and validation summary report.

·       Assist in documenting the Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.

 

Qualification:

This position requires a minimum of a bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses

Software Developer

AT0017
2022-09-22

·        Responsible for continuous improvement of DevOps tools, processes, and procedures, as well as the deployment and troubleshooting of complex cloud solutions.

·        Build, maintain, and scale infrastructure for application environments.

·        Work with a variety of platforms including SCM Continuous Integration and Continuous Development along with Build and Release Management. Administration and deploying development CI/CD tools such as Git/Bitbucket, Jira, GitLab, Jenkins, Puppet, Bamboo, Confluence, Spunk, ELK, Nagios, Grafana, Servicenow, Teams, ControlM, Airflow, CloudWatch, Solarwind, etc.

·        Implement AWS services VPC, EC2, S3, RDS, IAM, Elastic load balancing, Auto scaling, Cloud Front, Elastic Beanstalk, Cloud Watch focusing on high-availability, fault tolerance, auto scaling in AWS Cloud.

·        Manage Ansible Playbooks with Ansible roles. Use file module in Ansible playbook to copy and remove files on remote systems. Create inventory in Ansible for automating the continuous deployment and written playbooks using YAML scripting.

·        Built Docker images using related base image that encapsulates different application versions which is deployed on AWS by configuring task and Services. Used Launch configuration and Lifecycle hooks to automate auto scaling by defining the metrics.

·        Deploy application which is containerized using Docker onto a Kubernetes cluster which is managed by Amazon Elastic Container Service for Kubernetes (EKS).

·        Setting up monitoring and alerting for Kubernetes cluster using open-source monitoring tools like Grafana, Prometheus.

·        Install Jenkins on Linux environment and integrated different tools like Maven, GIT, SonarQube, and Nexus with Jenkins and implemented master - slave configurations to run multiple build operations.

·        Own production incidents/issues and provide application support during and – on occasion –outside of normal business hours, responding to infrastructure incidents and alerts and escalating to other subject matter experts as necessary.

 

Qualification:

This position requires a minimum of  bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Java Developer

AT0016
2022-03-22


·        Analyzing the user requirements set on the Kanban board and gathering the requirement to get the issue resolved.

·        Debugging the code by adding breakpoints on Eclipse IDE, looking for the Splunk logs, checking SP Tool, and fetching records from BETA if issues noticed.

·        Implementing well-defined and efficient Java, JavaScript, and AngularJS code as per the requirement in the Kanban board.

·        Ensuring that the code design follows the preset guidelines.

·        Coding JUnit tests for the corresponding Java code for that month’s release.

·        Performing regression tests to check the software’s functionality with the rest of the components and ensuring the system is working as expected.

·        Testing the correct endpoints are being hit on the backend through Postman.

·        Developing Confluence pages providing an overview of the system, code, and testing, for future reference.

·        Participating in Software Development Life Cycle stages.

 

Qualification:

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Java Developer

AT0015
2022-01-20


·       Work within the rules team in conjunction with technology teams and business partners to design and develop business rules using Redhat Process Automation Manager and Java.

·       Design and develop various business processes and required work item handlers using drools, Java.

·       Understand and provide resolution for various business problems by architecting best technical solution in Redhat PAM.

·       Participate in designing and development of lean business process flow for redhat PAM along with technical teams.

·       SME support/Consultation for migration activities.

·       Design and implement end to end testing of rules using postman and automating the test cases using Cucumber.

·       Help development teams to solve day to day implementation issues.

·       Synchronize multiple teams to solve day to day implementation issues.

 

Qualification:

 

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Qlik Developer

AT0014
2022-08-22

·        Provide Knowledge Transfer of Current Business Processes for creating daily reports as directed by the Department.

·        Assess and determine best data workflows as directed by the Department.

·        Configure Qlik Data Connections to Source System(s) daily as directed by the Department.

·        Access and prepare Data Tables for Analytic-Ready Data Model as directed by the Department.

·        Create Qlik Scripting as directed by the Department.

·        Provide and create Qlik Data Modeling as directed by the Department.

·        Create and test Qlik application and dashboard design as directed by the Department.

·        Create Qlik Wireframing as directed by the Department.

·        Provide visualization development as directed by the Department.

·        Configure behavior of visualizations and dashboard as directed by the Department.

·        Provide layout testing as directed by the Department.

·        Develop customization and aesthetics for Qlik as directed by the Department.

·        Apply security modeling as directed by the Department.

·        Create   and provide testing for application/dashboard functionality as directed by the Department.

·        Provide Application Migration from Dev to Production Environment.

·        Create scheduling reload tasks to refresh data and Automate Process for Qlik application as directed by the Department.

·        Configure integration with Qlik N Printing for Scheduled Distribution as directed by the Department.

·        Design Reports –PDF, Microsoft Office, HTML, etc. as directed by the Department.

·        Deploy application on scheduled basis to as directed by the Department.

·        Provide training and handoff of new Qlik Dashboard as directed by the Department.

Qualification:

This position requires a minimum of a Bachelor’s degree in Computer Science, Computer Information Systems, Information Technology or a combination of education and experience equating to the U.S. equivalent of a Bachelor’s degree in one of the aforementioned courses.  

Equipment QC Eng

AT0013
2022-08-10

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT0012
2022-08-09

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT0011
2022-08-08

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT0010
2022-08-05

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT009
2022-08-04

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT008
2022-08-03

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT007
2022-08-02

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT006
2022-08-01

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT005
2022-07-29

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT004
2022-07-28

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Equipment QC Eng

AT003
2022-07-27

Equipment QC Eng:       

Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 


Salary:                                $84,885/year


Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)


Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.


Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 


Contact:                   Moushmi Saha, HR Manager

                                  Aplomb Technologies, Inc

                                  careers@aplombtek.com

                                  101 College Road East, Suite 301

                                  Princeton, NJ 08540

                   

Senior Software developer

AT002
2022-06-11

hai this is for testing