CQV Specialist

We are seeking a Senior CQV Specialist to lead commissioning, qualification, and validation activities for facility, equipment, and computerized systems supporting GMP cell therapy manufacturing.

This individual will own qualification strategy and execution, ensuring compliant, risk‑based validation aligned with USP, GAMP 5, and industry best practices.

• Lead and own CQV activities across facility, QC, process, and computerized systems, including clean rooms, smoke studies, and qualified equipment.
• Develop and execute robust, risk‑based qualification strategies grounded in USP, GAMP 5, and system impact assessments (ISP guidelines).
• Author and execute validation plans, protocols, reports, risk assessments, and GxP documentation.
• Drive execution activities, proactively resolving issues, deviations, and remediation items during qualification.
• Lead deviation investigations, impact assessments, and corrective actions.
• Support qualification of cell‑therapy‑specific and QC systems such as qPCR, BacT, Faxitron, and microplate readers.
• Quickly onboard to new projects and scopes, independently managing execution from planning through approval.
• Represent CQV activities during internal and regulatory inspections as needed.

• 8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (cell therapy strongly preferred).
• Hands‑on experience qualifying facility, equipment, and computerized systems.
• Strong working knowledge of USP, GAMP 5, and risk‑based validation methodologies.
• Demonstrated experience owning validation programs, writing protocols, executing testing, and managing deviations.
• Ability to understand complex scope, define qualification impact, and implement compliant execution strategies.
• Excellent communication skills and ability to lead independently in fast‑paced GMP environments.