Biologics Validation Expert

7 days ago


Copenhagen, Copenhagen, Denmark AGC Inc Full time

We are seeking a highly skilled Biologics Validation Expert to join our team at AGC Inc. This is an exciting opportunity for a motivated and experienced professional to contribute to the development of life-changing therapies.

About AGC Inc

AGC Inc is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service. Our mission is to work side-by-side with our clients and partners to bring new biopharmaceuticals to market, improving patients' lives around the globe.

Job Summary

The Biologics Validation Expert will support our Engineering, Facility/Labs, and Automation Manufacturing Support teams in scale-up and manufacturing of cGMP protein-based therapeutics, including cell and gene therapies. Key responsibilities include cross-functional investigations and closure of quality events, review and approval of validation documents and strategies, and evaluation of risk assessments.

Key Responsibilities:
  • Design, develop, and lead Equipment and Facility Validation initiatives.
  • Ensure the Validation Master Plan remains current.
  • Prepare and execute IQ/OQ/PQ protocols for equipment, instruments, facilities, and utilities, as well as related software, to ensure compliance and adherence to cGMP and AGC Inc validation standards.
  • Identify and resolve non-conformances/deviations encountered during IQ/OQ/PQ execution and work with cross-functional teams to implement mitigation solutions.
  • Generate and review qualification reports and help summarize results that may be viewed by clients and regulatory agencies.
Requirements:
  • BA or BS with at least 8 years QA-related validation experience or equivalent work experience or a Master degree in a scientific discipline with at least 6 years related experience; may include equivalent work experience in a cGMP manufacturing facility.
  • Experience with application of validation compliance and principles of quality that drive QA strategy and oversight.
  • Experience in facilitating change control, deviations/investigations, and closure.
  • Knowledge/Experience in Corrective and Preventative Action (CAPA) facilitation and closure.
Benefits:
  • A competitive salary range of $94,000 - $129,250.
  • A friendly, collaborative culture that values personal initiative and professional achievement.
  • An equal opportunity employer that values diversity and inclusion.


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