Sr 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 < 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.