8+ years in CQV/validation within GMP pharmaceutical, biotech, or cell therapy (preferably cell therapy)
Hands-on experience with qualification of facilities, equipment, and computerized systems
Strong understanding of USP, GAMP 5, and risk-based validation frameworks
Proven track record in owning validation programs and writing protocols
Ability to analyze complex qualifications and develop compliant execution strategies
Excellent communication skills, capable of independent leadership in fast-paced GMP environments
Responsibilities
Lead and manage CQV activities for facilities, QC, processes, and computerized systems
Develop and implement robust, risk-based qualification strategies
Author and execute validation documents including plans and reports
Proactively address issues, deviations, and remediation during qualification
Conduct deviation investigations and implement corrective actions
Support qualification of specialized cell therapy and QC systems
Quickly adapt and manage new project scopes from planning to approval
Represent CQV during internal and regulatory inspections
Benefits
Comprehensive health, dental, and vision insurance
401(k) retirement plan with company matching
Professional development and training opportunities
Flexible working hours and potential remote work options
Generous paid time off and holiday schedule
Full Job Description
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 , 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.
