8+ years of CQV/validation experience in GMP pharmaceutical, biotech, or cell therapy manufacturing (preferred).
Hands-on experience qualifying facilities, equipment, and computerized systems.
Strong knowledge of USP, GAMP 5, and risk-based validation methodologies.
Proven experience owning validation programs and managing deviations.
Capacity to understand complex scopes and define qualification impacts.
Excellent communication skills for leading in fast-paced GMP environments.
Responsibilities
Lead CQV activities across facilities, QC processes, and computerized systems.
Develop and execute risk-based qualification strategies according to industry standards.
Author and execute validation plans, protocols, and GxP documentation.
Proactively resolve issues and manage deviations during qualification.
Lead investigations, impact assessments, and corrective actions related to deviations.
Support qualification of cell therapy and QC systems like qPCR and microplate readers.
Understand new projects quickly and manage execution independently.
Benefits
Opportunity to lead critical validation activities in innovative cell therapy manufacturing.
Access to cutting-edge technology and methodologies in the biotech field.
Exposure to a collaborative work environment focused on compliance and quality.
Involvement in both internal and regulatory inspections, enhancing professional growth.
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).
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.
