8+ years of validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (cell therapy strongly preferred).
Hands-on experience qualifying facilities, equipment, and computerized systems.
In-depth understanding of USP, GAMP 5, and risk-based validation methodologies.
Proven track record managing validation programs and deviations.
Ability to define qualification impacts and implement compliant execution strategies.
Strong communication skills with a leadership presence in fast-paced GMP environments.
Responsibilities
Lead CQV activities for facilities, QC, processes, and computerized systems.
Develop and execute risk-based qualification strategies based on industry standards.
Author and execute validation plans, protocols, and GxP documentation.
Proactively resolve issues and deviations during the qualification process.
Conduct deviation investigations, impact assessments, and corrective actions.
Support the qualification of cell therapy-specific and QC systems.
Independently manage execution from planning to approval for new projects.
Represent CQV during internal and regulatory inspections when needed.
Benefits
Opportunity to lead critical validation activities in the cell therapy space.
Engage in diverse projects involving innovative biotechnological applications.
Chance to work in a fast-paced, dynamic environment with a strong focus on compliance.
Collaboration with cross-functional teams enhancing broad pharmaceutical exposure.
Professional development opportunities in advanced validation methodologies.
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.
