Validation Manager

2 weeks ago

Sawston Cambridgeshire, United Kingdom Next Phase Recruitment Full time
Job Description

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:

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

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