MSAT Validation Engineer: Drive GMP Process Excellence, Leiden

For a leading biopharmaceutical manufacturing site in Leiden, we are looking for an Engineer MSAT to strengthen the Manufacturing Science&Technology (MSAT) team within the Supporting Process Validation (SPV) function. About the role In this position, you will support the validation of critical manufacturing processes in a GMP-regulated environment. You will play a key role in ensuring process robustness, compliance, and continuous improvement across site operations.Key responsibilities• Plan, execute, and document process validation activities (including cleaning, mixing, sterilization, and hold time studies) • Draft, review, and approve validation protocols and reports • Support process improvements, standardisation, and benchmarking initiatives • Contribute to technology transfers and introduction of new processes or equipment• Ensure audit and inspection readiness in line with GMP requirements • Collaborate with cross-functional stakeholders in Manufacturing, Quality, and MSAT Your profile • Bachelor’s degree in Science, Engineering, or a related technical field • Minimum of 2 years’ experience in the (bio)pharmaceutical industry or validation-related roles• Strong understanding of GMP and regulatory frameworks (FDA, EMA, ICH guidelines) • Experience with validation activities such as cleaning validation or hold time studies is an advantage • Structured, detail-oriented, and strong communication skills • Proactive mindset with the ability to work effectively in cross-functional teams

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