8+ years of CQV/validation experience in GMP pharmaceutical or biotech environments, with a focus on cell therapy preferred.
Hands-on expertise in qualifying facilities, equipment, and computerized systems.
Solid understanding of USP and GAMP 5 guidelines, with knowledge of risk-based methodologies.
Proven history of managing validation programs, including protocol writing and deviation management.
Ability to assess complex scopes and develop compliant qualification strategies independently.
Strong communication skills, with a capacity to lead and collaborate effectively in fast-paced settings.
Responsibilities
Lead CQV activities for facilities, QC processes, and computerized systems, including cleanrooms and equipment.
Develop and implement risk-based qualification strategies in accordance with industry standards.
Author and execute comprehensive validation plans, protocols, and GxP documentation.
Drive execution of qualification activities, addressing issues and deviations as they arise.
Lead investigations into deviations and implement corrective actions based on impact assessments.
Support the qualification of specialized cell therapy and QC systems, including qPCR and microplate readers.
Quickly adapt to new projects and manage execution from planning to approval.
Represent CQV during internal audits and regulatory inspections as required.
Benefits
Opportunity to work in cutting-edge cell therapy manufacturing.
Autonomous role with leadership over critical CQV initiatives.
Direct contribution to the compliance and quality of innovative healthcare solutions.
Engagement with advanced validation methodologies and technologies.
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).
uthor 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.
