8+ years of experience in CQV/validation, preferably in GMP pharmaceutical, biotech, or cell therapy manufacturing.
Hands-on experience with qualifying facilities, equipment, and computerized systems.
In-depth knowledge of USP, GAMP 5, and risk-based validation methodologies.
Proven track record of managing validation programs, including writing protocols and executing tests.
Strong problem-solving skills to assess qualification impacts and implement strategies.
Excellent verbal and written communication skills, with the ability to lead in dynamic GMP settings.
Responsibilities
Lead and manage all CQV activities for facilities, QC processes, and computerized systems.
Develop and implement thorough, risk-based qualification strategies according to industry standards.
Author and execute comprehensive validation documents, including plans, protocols, and reports.
Proactively identify and resolve issues during the qualification process, including deviations and remediation.
Conduct deviation investigations and execute impact assessments with corrective actions as needed.
Support qualification for cell therapy-specific and QC systems such as qPCR and microplate readers.
Take ownership of new projects, managing their execution from planning through to final approval.
Benefits
Opportunity to work on cutting-edge cell therapy manufacturing processes.
Autonomy in leading substantial CQV initiatives, contributing to impactful projects.
Involvement in both internal and regulatory inspections, enhancing professional visibility and experience.
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.
