Sr. CQV Engineer

We are seeking a Senior CQV Specialist to lead commissioning, qualification, and validation (CQV) activities for GMP facilities, equipment, and computerized systems supporting cell therapy manufacturing. This role will own qualification strategy and execution, ensuring compliant, risk‑based validation aligned with USP, GAMP5, and industry best practices. The ideal candidate can step into multiple projects quickly and operate with minimal oversight in a fast‑paced GMP environment.

• Lead and execute CQV activities across facilities, process equipment, QC equipment, and computerized systems.
• Perform cleanroom qualifications including smoke studies and environmental assessments.
• Develop and execute risk‑based qualification strategies in alignment with USP, GAMP5, and system impact assessments.
• Author and execute validation plans, protocols (IQ/OQ/PQ), reports, risk assessments, and GxP documentation.
• Drive execution activities and proactively resolve issues, deviations, and remediation actions during qualification.
• Lead deviation investigations, impact assessments, and corrective/preventive actions.
• Support qualification of cell therapy–specific and QC systems (e.g., qPCR, BacT, Faxitron, microplate readers).
• Independently manage validation activities from planning through final approval.
• Support internal and regulatory inspections related to CQV activities.

• 8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (cell therapy experience strongly preferred).
• Hands‑on experience qualifying facilities, utilities, process equipment, QC equipment, and computerized systems.
• Strong working knowledge of USP, GAMP5, and risk‑based validation methodologies.
• Proven experience owning validation programs, writing protocols, executing testing, and managing deviations.
• Ability to assess complex systems, define qualification impact, and implement compliant execution strategies.
• Strong communication skills with the ability to work independently and manage multiple deliverables simultaneously.