CQV Specialist

• We are seeking a 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 <1058>, GAMP 5, and industry best practices.

Responsibilities:

• Lead and own CQV activities across facility, QC, process, and computerized systems, including cleanrooms, smoke studies, and qualified equipment.
• Develop and execute robust, risk-based qualification strategies grounded in USP <1058>, 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.

Requirements:

• 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 <1058>, 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.