Engineer

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Engineer MSAT Validation, Leiden, Zuid-Holland
Location: Leiden, Zuid-Holland | Sector: Pharmaceuticals | Start Date: 7/28/2026 | Job ref: 58545
The Company
A leading biopharmaceutical manufacturing organization focused on the development and production of high-quality biologic medicines. The company operates in a highly regulated environment and is committed to innovation, quality, compliance, and continuous improvement across its manufacturing processes.
About the Role
We are seeking an Engineer MSAT Validation to support process validation activities within biologics drug substance manufacturing. This role focuses on ensuring manufacturing processes are validated, compliant with regulatory requirements, and optimized for commercial production. You will work closely with technical, quality, and manufacturing teams to execute validation projects and drive operational excellence.
Responsibilities
-Plan, coordinate, and execute supporting process validation activities
-Conduct mixing validation, buffer hold time validation, microbial hold time validation, and moist heat sterilization qualification
-Prepare, review, and maintain validation protocols, reports, and support documentation
-Support validation and qualification activities for both new and existing manufacturing processes
-Execute performance qualification activities related to change controls and improvement projects
-Collaborate with cross functional teams to deliver validation activities according to project timelines
-Ensure compliance with GMP requirements and ALCOA plus data integrity principles
-Identify opportunities for process optimization, standardization, and continuous improvement
-Support adherence to quality, safety, and regulatory requirements
Requirements
-Master's degree in biotechnology, Biochemical Engineering, Chemical Engineering, or a related discipline with up to two years of relevant experience
-Alternativel...