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.
Big Data Engineer
AT0092
2023-05-25
●
Partner with internal stakeholders to understand business
requirements, work with cross-functional data and product teams and build
efficient and scalable data solutions.
●
Work in various phases of the software development life cycle right
from Requirements gathering, Analysis, Design, Development, and Testing to
Production.
●
Develop sustainable distributed data management solutions and
workflows required for Data migration to cloud to enable analytics and derive
business insights.
●
Build and maintain infrastructure pipelines for data extraction,
transformation and loading of data from a variety of sources. Analyze data both
in real-time and batch processing utilizing Spark, Kafka, Hadoop, and AWS
technologies such as Kinesis, S3, ElastiCache, and Lambda.
●
Ensure overall data and code
quality via Unit and Integration Tests. Troubleshoot and resolve issues in test
and production environments. Employ CI/CD practices using Jenkins, Bogie and
version control system GIT.
●
Identify and implement internal process improvements: automating
manual processes, optimizing data delivery, re-designing infrastructure for
greater scalability.
Qualification:
This position requires a minimum of a Bachelor’s
Degree or its equivalent in Computer Science.
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0083
2023-06-02
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0076
2023-06-01
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0070
2023-05-31
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0064
2023-05-30
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0058
2023-05-29
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0052
2023-05-26
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0046
2023-05-25
Salary: $91,270/year
Work Schedule: 8:30 am-5:30pm; 40 Hrs/week (M-F)
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.
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.
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.
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.
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.
101 College Road East, Suite 301
Princeton, NJ 08540
Data Engineer
AT0040
2023-05-24
Salary: $91,270/year
Work
Schedule: 8:30 am-5:30pm;
40 Hrs/week (M-F)
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.
Data Scientist
AT0035
2023-05-25
·
Identify
valuable data sources, automate collection processes, and undertake
preprocessing of structured and unstructured data.
·
Analyze
large amounts of information to discover trends, patterns and build predictive
models, machine-learning algorithms.
·
Combine
models through ensemble modeling and present information using data
visualization techniques.
·
Propose
solutions, strategies to business challenges and collaborate with engineering,
product development teams.
·
Create
and maintain data pipeline architecture on the Azure platform. Ensure that
system designs adhere to solution architecture design and are traceable to
functional and non-functional requirements.
·
Leverage
Azure Data Factory and Databricks to assemble large, complex data sets. Design
new solutions and services to improve overall user experience.
·
Identify,
design, and implement internal process improvements: automating manual
processes, optimizing data delivery, re-designing infrastructure for greater
scalability, etc.
·
Build
the infrastructure required for optimal extraction, transformation, and loading
of data from a wide variety of data sources using SQL and Azure ‘big data’
technologies.
·
Build
analytics tools that utilize the data pipeline to provide actionable insights
into customer acquisition, operational efficiency and other key business
performance metrics.
·
Work
with stakeholders including the Executive, Product, Data and Design teams to
assist with data-related technical issues and support their data infrastructure
needs.
·
Create
data tools for analytics and data scientist team members that assist them in
building and optimizing our product into an innovative industry leader.
·
Work
with data and analytics experts to strive for greater functionality in the data
systems.
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.
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.
Data Engineer
AT0019
2023-02-07
•
Gathering requirements to understand requests
and needs to provide the best solution possible.
•
Executing design, development & deployment
of ETL applications, preparing High Level Design & Low-Level Design
Documents Developing interfaces, packages, and load plans.
•
Leading team to handle complex business rules
while balancing the fulfillment of stringent performance requirements.
•
Performed end-to-end delivery of Pyspark, Spark
SQL, Azure Data Warehouse (ADW), CI/CD and Production Support.
•
Wrote scripts in Hive SQL for creating complex
tables with high performance metrics like partitioning, clustering and skewing.
•
Worked with google data catalog and other google
cloud APIs for monitoring, query and billing related analysis for Big Query
usage.
•
Designing and developing code, scripts and data
pipelines that leverage structured and unstructured data integrated from
multiple sources.
•
Implementing Data warehouse solution consisting
of ETLs, on-premises to Cloud Migration and building and deploying batch and
streaming data pipelines on cloud environments.
•
Investigate Data Quality issues and generate
presentable narratives based on biases possible due to incompleteness of data.
• Monitoring project progress & outstanding
issues and ensuring the quality of the deliverables by onducting daily defect
review meetings & extending post-implementation support to team members by
defining standard practices.
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 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
2022-06-11hai this is for testing
Software Developer
AT001
2022-06-09hai this is for testing