Sr. CSV Engineer

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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.
• Develop and modify validation documentation including User Requirements Specifications (URS), Design Reviews (DR), Criticality assessments, CSV protocols (SAT, IQ, OQ, PQ) which verify compliance with regulatory and client requirements, reports summarizing protocol results, exception reports identifying defects, and review of vendor documentation.

• A strong understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
• MES expertise is required.
• Resource must work from Bothell location.
• 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.

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

Mid-Senior level

Full-time

Engineering and Information Technology

Civil Engineering