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Lead C&Q Engineer
Posted 5 months ago
Job summary
Seeking a Lead C&Q Engineer for a biopharma project responsible for overseeing commissioning and qualification activities on bioprocess systems, ensuring compliance with GMP and regulatory standards, managing resources, coordinating with vendors and teams, and providing leadership for complex biopharma systems.
Responsibilities
Lead the full lifecycle of Commissioning and Qualification activities for upstream and downstream bioprocessing systems on a large-scale biopharma project. Coordinate with cross-functional teams and vendors to ensure system readiness, regulatory compliance, and seamless handover to operations.
Qualifications
Requires a degree in Engineering, Biotechnology, or Pharmaceutical Sciences with over 5 years of experience in CQV and validation. Must possess strong knowledge of GMP, FDA/EMA regulations, and hands-on experience with bioreactors and filtration systems.
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