Senior CQV Project Manager
Blackfield Associates
Occitanie
Senior CQV Project Manager – Initial 12 month contract
Blackfield Associates are seeking a Senior CQV Project Manager to lead the technical transfer, commissioning, qualification, and validation of bioprocessing equipment into a new facility. This role ensures that all equipment meets GMP, regulatory, and operational requirements for seamless process integration.
Key Responsibilities:
- Oversee the end-to-end technical transfer of bioprocessing equipment, ensuring compliance with project timelines and budgets.
- Lead CQV activities (FAT, SAT, IQ, OQ, PQ) for equipment such as bioreactors, chromatography skids, and filtration units
- Collaborate with engineering, validation, manufacturing, and quality teams to ensure equipment readiness.
- Develop and execute CQV protocols, risk assessments, and validation reports in compliance with regulatory standards.
- Identify and resolve technical challenges, ensuring smooth facility startup.
- Act as the primary point of contact for stakeholders, including vendors and regulatory bodies.
Requirements:
- sufficient years of CQV experience in biopharmaceutical expansion projects.
- Strong knowledge of GMP regulations, validation lifecycle, and equipment qualification.
- Experience leading cross-functional teams in facility start-up and technical transfers.
- Excellent project management and problem-solving skills.
- Bachelor's or Master's degree in Engineering, Biotechnology, or a related field.
This is an exciting opportunity to lead a key facility expansion, ensuring equipment readiness for large-scale bioprocessing operations. If interested please apply or reach out to [email protected] for more details.