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Senior Validation Expert
2 months ago
About the Role:
Candidates with experience in validation activities within the biopharmaceutical ATMP or related sectors are sought by CK Group to join their team as a Senior Validation Specialist. This permanent position will be based at their site in Cambridge, UK.
Key Responsibilities:
- Support the implementation of a risk-based approach to the validation of systems to ensure compliance with Annex 11, 15, and industrial guidance such as GAMP 5 guidelines.
- Prepare validation plans, assist system owners with impact assessments, risk assessments, and identify validation requirements for equipment, facility, 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 (or equivalent) in a Science or related discipline.
- Experience leading validation activities within the biopharmaceutical ATMP or related sectors (e.g., cleanrooms).
- Knowledge of relevant regulations (GMP/ ICH/ FDA/ USP/ EP policies).
- Demonstrable experience of generation and execution of validation lifecycle documents (URS, DQ, IQ, OQ & PQ).
- Understanding and experience of aseptic processing and cleanroom technologies.
