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 and writing protocols
Ability to understand complex project scope and implement compliant execution strategies
Excellent communication skills, capable of independent leadership in fast-paced GMP environments
Responsibilities
Lead and own CQV activities across facility, QC, process, and computerized systems
Develop and execute risk-based qualification strategies
Author and execute validation plans, protocols, and reports
Drive execution activities, proactively resolving issues and deviations
Lead deviation investigations and corrective actions
Support qualification of cell therapy-specific and QC systems
Quickly onboard to new projects and independently manage execution
Benefits
Possibility of working in a cutting-edge area of cell therapy
Opportunity to shape qualification strategies and drive compliance
Engagement with cross-functional teams on complex projects
Role involves representation during internal and regulatory inspections
Independently manage aspects of CQV from planning to approval
Full Job Description
Job description:
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 , 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 , 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 , GAMP 5, and risk-based validation methodologies.
