Sr. CSV Engineer

Job Description

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• Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution.
• 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.
• Produce reports which summarize the results of the protocol executions and exception reports which identify defects or issues during test execution.
• Review vendor documentation.
• Requirement specification document review and approvals.
• 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 summary review.

• Excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
• MES expertise is required.
• Ability to work from Bothell, Washington.

• Requirement Document
• Validation/Test Plan
• Requirement Traceability Matrix
• Change Requests
• Test/Validation Summary Report

• Seniority level: Mid‑Senior level
• Employment type: Full‑time
• Job function: Engineering and Information Technology
• Industries: Civil Engineering
• Location: Bothell, Washington