Validation Engineer

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MSAT Validation Engineer, Leiden, Zuid-Holland
Location: Leiden, Zuid-Holland | Sector: Biotechnology | Start Date: 7/29/2026 | Job ref: 58558
The Company
Our client is a global biopharmaceutical company committed to advancing innovative medicines that improve patients' lives worldwide. Through cutting-edge research, advanced biologics manufacturing, and a strong focus on quality and innovation, the company delivers life-changing therapies across a wide range of therapeutic areas.
Role Description
As a MSAT Validation Engineer, you will plan, coordinate, and execute validation and qualification activities for biopharmaceutical manufacturing processes, including mixing, sterilization, and buffer/microbial hold time studies. You will ensure GMP compliance by preparing validation documentation, supporting process improvements, and driving performance qualification activities for clinical and commercial drug substance production.
Responsibilities - Plan, coordinate, and execute validation and qualification activities for biopharmaceutical manufacturing processes. - Prepare, review, and maintain validation protocols, reports, and GMP-compliant documentation. - Perform and support sterilization, mixing, and cleaning validation activities to ensure regulatory compliance. - Collaborate with Operations, Quality, and cross-functional teams to execute validation projects and support change controls. - Drive process improvements and provide technical support to the MSAT team during validation and qualification activities. - Ensure all validation activities comply with GMP standards and applicable regulatory guidelines.
Requirements - Bachelor's or Master's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, or a related Life Sciences field. - Hands-on experience in validation and/or qualification within a GMP-regulated biopharmaceutical or pharmaceutical environment. - Strong knowledge of ster...