MSAT Validation Engineer

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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