Senior Validation Specialist

CK Group are recruiting for a Validation Specialist to join a growing Cell Therapy CDMO to be based at their site in Cambridge on a permanent basis.

Job Summary:

• Responsible for leading validation, qualification and verification of manufacturing equipment, facilities and laboratory systems.
• Author, execute and report validation activities within the framework of GMP - Annex 11 & 15 and in compliance with the QMS requirements.
• Work with external companies to ensure activities thatrequire specialist knowledge are completed in a compliant manner.

You will have the following experience/qualifications:

• Experience leading qualification/validation activities within the biopharmaceutical, ATMP or related sectors (e.g. cleanrooms, lab equipment, monitoring systems).
• Demonstrable experience of validating manufacturing/laboratory equipment, facilities and processes including the generation/execution of lifecycle documents in a biopharmaceutical or related industry tothe required quality and regulatory standards (Annex 15 and 11).
• Experience of successful interfacing with multi-functional project teams and external contracted resources to develop requirements, establish programs and complete the validation.- A knowledge and understanding of how to implement the GAMP guidance.

To Apply:

For more information, or to apply for this Senior Validation Specialist position please contact James Horne on 0191 370 6483 or email jhorne@ckgroup.co.uk. Please quote job reference 56707 in all correspondence.

It is essential that applicants hold entitlement to work in the UK