Sr. CQV Specialist

Key Responsibilities Develop, execute, review, and maintain validation lifecycle documentation, including Risk Assessments, URS, Design Specifications, Traceability Matrices, Test Scripts, Validation Protocols, Deviations, Summary Reports, Periodic Reviews, and System Retirement Documentation. This role will provide hands-on support across Computerized System Validation (CSV) and Commissioning, Qualification, and Validation (CQV), with a focus on analytical laboratory instruments, computerized systems, and GMP equipment.

Job Title: CSV/CQV Validation Specialist
Location: Oregon
Work Arrangement: On-site
Employment Type: W2 Contract

Position Summary

We are seeking a CSV/CQV Validation Specialist to support qualification and validation activities within a regulated biopharmaceutical manufacturing environment. This role will provide hands-on support across Computerized System Validation (CSV) and Commissioning, Qualification, and Validation (CQV), with a focus on analytical laboratory instruments, computerized systems, and GMP equipment.

Key Responsibilities

• Develop, execute, review, and maintain validation lifecycle documentation, including Risk Assessments, URS, Design Specifications, Traceability Matrices, Test Scripts, Validation Protocols, Deviations, Summary Reports, Periodic Reviews, and System Retirement Documentation.
• Support qualification and validation of analytical laboratory instruments, computerized systems, and GMP equipment.
• Execute and support IQ, OQ, and PQ activities.
• Verify calibration readiness and support data integrity assessments.
• Ensure compliance with GxP requirements, 21 CFR Part 11, 21 CFR Parts 210/211, EU Annex 11, and Annex 15.
• Support change controls, impact assessments, deviations, CAPAs, and validation protocols.
• Use validation/documentation platforms such as Kneat or similar systems.
• Partner with Quality Control, Instrumentation, Engineering, Automation, Quality Assurance, and system owners.
• Monitor field execution, identify gaps, support discrepancy resolution, and escalate issues as appropriate.
• Maintain accurate and inspection-ready validation documentation.
• Support template development and continuous improvement initiatives.
• Manage multiple validation activities and competing priorities.
• Travel between site buildings as required.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biology, or related discipline preferred.
• 3 5 years of CSV, CQV, validation, or qualification experience in pharmaceutical, biotechnology, medical device, or other regulated industries.
• Experience with analytical laboratory instrument and equipment qualification.
• Experience working in a cGMP-regulated environment.
• Experience managing multiple validation projects and competing priorities.
• Strong understanding of GMP documentation and validation practices.
• Experience with computerized systems, laboratory instruments, GMP equipment, specifications, and engineering documentation.
• Experience with Kneat or similar validation platforms preferred.