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Lead Validation Engineer

2 months ago

Cambridge, Cambridgeshire, United Kingdom CK Group Full time
CK Group is seeking a skilled Lead Validation Engineer to become part of a dynamic Cell Therapy Contract Development and Manufacturing Organization (CDMO). This position is based at our facility in Cambridge and is a permanent, onsite role.

Key Responsibilities:
In this role, you will report directly to the Validation Manager and will be instrumental in supporting various projects. Your responsibilities will include:
  • Implementing 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.
  • Creating and executing validation protocols for equipment, facilities, utilities, computerized systems, and processes.
  • Overseeing the requalification processes for systems and equipment.
  • Supervising validation tests conducted by external vendors.
Candidate Profile:
The ideal candidate will possess:
  • A degree or equivalent qualification in a scientific discipline.
  • Proven experience in leading validation efforts within the biopharmaceutical Advanced Therapy Medicinal Products (ATMP) sector or similar environments.
  • In-depth knowledge of relevant regulations including GMP, ICH, FDA, USP, and EP.
  • Demonstrable expertise in the creation and execution of validation lifecycle documentation such as URS, DQ, IQ, OQ, and PQ.
  • A solid understanding of aseptic processing and cleanroom technologies.
Important Note:
Applicants must have the legal right to work in the UK. Please ensure to reference the job title in all communications.