Validation Manager

2 days ago


Cambridge, Cambridgeshire, United Kingdom CK Group Full time
Job Title: Validation Manager

CK Group is seeking a highly skilled Validation Manager to join their team on a permanent basis. The successful candidate will be based at their site in Cambridge and will be responsible for leading the Validation function.

The Role:

As a Validation Manager, you will be responsible for ensuring that all activities associated with manufacturing and lab equipment, facilities, utilities, laboratory, and computer systems are completed in accordance with GMP requirements.

Key Responsibilities:
  • Manage a team and ensure validation master plans (VMPs), protocols, and procedures are established.
  • Prepare and maintain validation plans (VPs) and identify validation requirements.
  • Assist in the authoring of User Requirement Specifications, DQ/IQ/OQ/PQ protocols, and reports for validation purposes.
  • Work with external companies and project teams to ensure activities that require specialist knowledge are completed.
  • Execute validation protocols for equipment, facilities, and utilities.
Your Background:

To be successful in this role, you will need:

  • A degree (or equivalent) in a Science or related discipline.
  • Qualifications related to validation and quality compliance (GMP/ ICH/ FDA/ USP/ EP policies).
  • Experience of validating manufacturing/laboratory equipment, facilities/utilities, and processes, including the generation of lifecycle documents (URS, DQ, IQ, OQ & PQ) in a biopharmaceutical.
  • Significant experience leading validation activities within the biopharmaceutical or ATMP sectors.
  • Understanding and experience of aseptic processing and cleanroom technologies.
  • A proven track record of establishing validation master plans (VMPs).
What We Offer:

CK Group is a leading provider of recruitment services to the life sciences industry. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth.

Please note that it is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.


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