We are seeking an experienced CQV Technical Lead to guide and oversee CQV activities for API, biotech processes, and filling lines projects. The successful candidate will be responsible for the implementation of the overall CQV strategy, development of key documentation, coordination with cross‑functional teams, and ultimate delivery of safe, robust, and compliant systems.
Key Responsibilities
Lead commissioning, qualification, and validation (CQV) activities for API production, biotech facilities, and filling lines (e.g., aseptic/sterile processing).
Develop, implement, and manage the overall project CQV strategy, aligned with project and business objectives, GMP, and regulatory requirements (FDA, EMA, etc.).
Prepare and review CQV documentation (FAT, SAT, IQ, OQ, PQ protocols & reports, Traceability Matrix, Risk Assessments, etc.).
Oversee vendor and contractor execution for CQV scopes, ensure rigorous testing and documentation standards are achieved.
Coordinate with QA, Engineering, Operations, and Project Management to ensure timely CQV deliverables.
Champion quality and compliance throughout the project lifecycle, identify potential risks or bottlenecks, and apply pragmatic solutions.
Lead and facilitate meetings, progress reviews, and technical discussions internally and with external partners.
Mentor and guide CQV engineers and junior staff as needed.
Support deviations, CAPA investigations, and change controls related to CQV scope.
Ensure project deliverables adhere to schedule and cost targets.
Requirements
Bachelor’s or Master’s degree in Engineering, Life Sciences, or related field (Chemical/Biotech/Mechanical Engineering preferred).
Minimum 10 years CQV experience in the pharmaceutical/biotech industry – focus on API, biotech, sterile operation and/or filling lines required.
Demonstrated expertise implementing or leading CQV strategy at a site or program level.
Proven track record preparing and executing CQV protocols for complex process equipment and utilities.
Strong knowledge of current GMP, regulatory, and safety standards.
Excellent organizational, documentation, and project leadership skills.
Experience working cross‑functionally in remote, global teams; strong communication and stakeholder management.
Willingness and flexibility for occasional site travel (as per project needs).
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