CSV Engineer

Summary

• Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
• 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 system compliance to regulatory and client requirements.
• Prepare and summarize reports that document the results of protocol executions and provide exception reports identifying defects or issues during test execution.
• Review vendor documentation and ensure adherence to validation requirements.
• MES expertise is required.
• Resource must work from the Bothell location.

• 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 and update RRA (Regulatory Risk Assessment) and obtain approvals.
• Post‑execution review and post approvals in ALM.
• CR Implementation approvals.
• Retirement Plan review and retirement summary review.
• Deliverables:
  Requirement document, Validation/Test Plan, Requirement Traceability Matrix, Change Requests, Impact assessment document, Test/Validation Summary Report.

• Experience preparing and executing test documentation for GMP computerized systems.
• Strong knowledge of regulatory requirements and validation methodologies.

• Entry level

• Contract

• Pharmaceutical Manufacturing