Validation Manager

5 days ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time

About the Role:

CK Group is seeking a highly experienced Validation Manager to lead the validation function for a growing Cell Therapy CDMO. This is a permanent position based at our site in Cambridge.

Key Responsibilities:

  • Lead the validation team and develop its capabilities to ensure activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed in accordance with GMP requirements.
  • Manage validation master plans (VMPs), protocols, and procedures to ensure compliance with regulatory requirements.
  • Prepare and maintain validation plans (VPs) and identify validation requirements to ensure seamless execution.
  • Collaborate with external companies and project teams to ensure activities requiring specialist knowledge are completed.
  • Execute validation protocols for equipment, facilities, and utilities to ensure quality and compliance.

Requirements:

  • Degree (or equivalent) in a Science or related discipline.
  • Qualifications related to validation and quality compliance (GMP/ ICH/ FDA/ USP/ EP policies).
  • Experience in validating manufacturing/laboratory equipment, facilities/utilities, and processes, including the generation of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical company.
  • Significant experience leading validation activities within the biopharmaceutical or ATMP sectors.
  • Understanding and experience of aseptic processing and cleanroom technologies.
  • Proven track record of establishing validation master plans (VMPs).

What We Offer:

Candidates must hold entitlement to work in the UK. We are an equal opportunities employer and welcome applications from all qualified candidates.


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