Company:
Maintec Technologies
Location: Princeton
Closing Date: 18/10/2024
Hours: Full Time
Type: Permanent
Job Requirements / Description
Job Title - Sr. Validation Engineer (CSV)
Location - Princeton, NJ (Day 1 Onsite)
Duration - Long term
Job Description:
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
Should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies
Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation
Skills:
Requirement Specification document review and approvals
System Implementation Plan Review
System Implementation Summary Report Review
Review and Pre-Approve ST/UAT Test Scripts in ALM
Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
Post Execution Review and Post Approvals in ALM
CR Implementation Approvals
Retirement Plan Review
Retirement Summary review Deliverables:
Requirement document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Impact assessment document
Test/Validation Summary Report
Location - Princeton, NJ (Day 1 Onsite)
Duration - Long term
Job Description:
Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
Should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies
Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements Reports which summarize the results of the protocol executions Exception reports which identify defects or issues during test execution Review vendor documentation
Skills:
Requirement Specification document review and approvals
System Implementation Plan Review
System Implementation Summary Report Review
Review and Pre-Approve ST/UAT Test Scripts in ALM
Create, Update RRA (Regulatory Risk Assessment) and obtain approvals
Post Execution Review and Post Approvals in ALM
CR Implementation Approvals
Retirement Plan Review
Retirement Summary review Deliverables:
Requirement document
Validation/Test Plan
Requirement Traceability Matrix
Change Requests
Impact assessment document
Test/Validation Summary Report
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