CQV Specialist
Katalyst Healthcares and Life Sciences
Job description
- 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.
- 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.
- 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.
Vacancy posted 1 day ago
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