Senior CQV Project Manager – Occitanie

Senior CQV Project Manager

Blackfield Associates

Occitanie

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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.

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