Validation Specialist

4 months ago

Sawston, United Kingdom AdventBio Full time

Company Information

Advent Bioservices is a growing Contract Development and Manufacturing Organisation (CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development of complex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated using advanced therapy medicinal products. We currently manufacture in aseptic suites in London and at our newly licenced facility in Sawston, Cambridge.

Job Summary

The Validation Specialist will be responsible for leading validation, qualification and verification of manufacturing equipment, facilities and laboratory systems. You will be required to author, execute and report validation activities within the framework of GMP - Annex 11 & 15 and in compliance with the QMS requirements. The role will involve working with external companies to ensure activities that require 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 to the 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.
- Ability to manage multiple and varied tasks and prioritise workload with attention to detail and targeting deadlines.
- Excellent oral and written communication skills.
- Able to evaluate complex situations and find solutions for them in a professional manner.
- Flexibility towards work assignments and new learning.
- Ability to quickly establish credibility and build rapport and trust.

The is a fantastic opportunity to join the Quality team for a growing organisation.

We offer an attractive base salary and benefits package.

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