Lead Validation Expert

3 weeks ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time
CK Group is seeking a qualified Lead Validation Expert to become part of a dynamic Cell Therapy Contract Development and Manufacturing Organization (CDMO). This position will be based at our Cambridge facility and is a permanent role that requires full onsite presence.

Position Overview:
In this role, you will report directly to the Validation Manager and play a crucial part in supporting various projects. You will collaborate with project teams and other departments to uphold validation standards. Additionally, you will have the opportunity to act on behalf of the Validation Manager when necessary.

Key Responsibilities:
  • Facilitating the adoption of a risk-based methodology for the validation of systems, ensuring adherence to Annex 11, 15, and industry standards such as GAMP 5.
  • Developing validation strategies, assisting system owners with impact and risk assessments, and determining validation needs for equipment, facilities, and systems projects.
  • Creating and executing validation protocols for equipment, facilities, utilities, computerized systems, and processes.
  • Overseeing the requalification processes for systems and equipment.
  • Managing validation testing conducted by external vendors.
Candidate Profile:
  • A degree or equivalent qualification in a scientific or related field.
  • Proven experience in leading validation efforts within the biopharmaceutical Advanced Therapy Medicinal Products (ATMP) sector or similar environments (e.g., cleanrooms).
  • In-depth knowledge of applicable regulations (GMP/ICH/FDA/USP/EP).
  • Demonstrated expertise in generating and executing validation lifecycle documentation (URS, DQ, IQ, OQ & PQ).
  • Familiarity with aseptic processing and cleanroom technologies.
Note:
It is essential that candidates possess the right to work in the UK. Please reference the job title in all communications.

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