Validation Engineer - MSAT, Leiden, Zuid-Holland

The Company
Our client is a global leader in biopharmaceutical innovation, dedicated to developing and manufacturing advanced biologic medicines and vaccines. With cutting-edge facilities and a strong focus on quality, safety, and sustainability, the site plays a vital role in supplying both clinical and commercial products worldwide. 

Role Description
As a Validation Engineer - MSAT, you will play a key role in leading and executing validation activities for supporting processes such as cleaning, mixing, sterilization, and holding time within biopharmaceutical manufacturing. You will drive process improvements, ensure compliance with regulatory standards, and contribute to the implementation of new technologies. 

Responsibilities
- Lead, plan, and execute validation activities for supporting processes (cleaning, mixing, sterilization, holding time).
- Define validation strategies, conduct change control assessments, and ensure documentation accuracy.
- Prepare, review, and approve validation protocols and reports.
- Collaborate with project teams to align timelines, communicate progress, and resolve technical challenges.
- Support audit and inspection readiness activities.
- Drive process improvements, standardization, and new technology implementation.
- Ensure adherence to company quality, safety, and compliance standards.

Requirements
- Bachelor’s or Master’s degree in Science, Engineering, or a related technical field.
- Minimum 4 years of relevant experience in the (bio)pharmaceutical industry or equivalent academic experience.
- Strong knowledge of validation principles, including cleaning, mixing, sterilization, and holding time studies.
- Familiarity with regulatory requirements and industry guidelines (FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).
- Excellent skills in planning, documentation, communication, and problem-solving.
- Experience with risk management and root cause analysis.
- Preferred: Experience with Lean, Six Sigma, or similar continuous improvement methodologies.

Other Information
If you are interested in this opportunity and believe your profile matches the requirements, please submit your application via the Apply button below.

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