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Validation Manager

4 months ago

Sawston, United Kingdom Next Phase Recruitment Full time

I am currently supporting a CDMO based in Sawston that provide GMP manufacturing of ATMP's and related products, process development and ancillary services in their search for a Validation Manager.


In this role you will be responsible for leading validation, qualification and verification of manufacturing equipment, facilities and lab systems.


Key Responsibilities:


1. Compliance & Implementation: Support the implementation of a risk-based approach to system validation to ensure compliance with Annex 11, 15, GAMP 5 guidelines, and company quality standards.


2. Validation Documentation: Establish and maintain validation master plans, protocols, and procedures to meet quality and regulatory standards.


3. Validation Planning & Support: Prepare and maintain validation plans, assist with impact assessments, identify validation requirements, and help author validation-related documents (e.g., User Requirement Specifications, DQ/IQ/OQ/PQ protocols).


4. Execution & Supervision: Execute validation protocols, manage requalification of systems and equipment, supervise vendor validation testing, review results, and resolve issues.


Role Requirements:


  1. BSc or MSC in a life science subject or comparable experience
  2. Experience leading validation / qualification activities within the biopharmaceutical ATMP or related sector (e.g cleanrooms, production/ lab equipment, monitoring systems)
  3. Clear working experience of generation and execution of validation lifecycle documents in adherence to Annex 11 and Annex 15.
  4. Experience of Aseptic processing and cleanroom operation