Senior Validation Specialist

3 days ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time
About the Role

CK Group is seeking an experienced Senior Validation Specialist to join their team in Cambridge, UK. This is a permanent position that requires full-time onsite work.

Key Responsibilities
  • Support the implementation of a risk-based approach to validation, ensuring compliance with Annex 11, 15, and GAMP 5 guidelines.
  • Develop validation plans, assist system owners with impact assessments, and identify validation requirements for equipment, facilities, and systems projects.
  • Prepare and execute validation protocols for equipment, facilities, utilities, computerized systems, and processes.
  • Manage requalification of systems and equipment.
  • Supervise validation testing performed by vendors.
Requirements
  • Degree in a Science or related discipline.
  • Experience leading validation activities in the biopharmaceutical ATMP or related sectors.
  • Knowledge of relevant regulations (GMP/ ICH/ FDA/ USP/ EP policies).
  • Demonstrable experience of generating and executing validation lifecycle documents (URS, DQ, IQ, OQ & PQ).
  • Understanding and experience of aseptic processing and cleanroom technologies.
What We Offer

CK Group is a growing Cell Therapy CDMO with a commitment to excellence. As a Senior Validation Specialist, you will have the opportunity to work with a talented team and contribute to the success of the company.



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