MSAT Validation Engineer

Responsible for supporting validation activities for biotherapeutic drug substance manufacturing within a GMP-regulated biotechnology environment. The role focuses on planning, coordinating, and executing Supporting Process Validation (SPV) activities to ensure manufacturing processes remain compliant, robust, and inspection-ready. Responsibilities include validation of supporting processes such as mixing, buffer hold time, microbial hold time, and moist heat sterilization, writing and reviewing validation documentation, supporting process qualification and change control activities, driving process improvements and standardization initiatives, ensuring compliance with GMP and data integrity requirements, and collaborating with cross-functional teams to deliver clinical and commercial manufacturing projects.

• Bachelor's degree with 2+ years of relevant experience, or Master's degree in Biotechnology, (Bio)Chemical Engineering, or another relevant scientific or engineering discipline
• Experience in the pharmaceutical, biotechnology, biopharmaceutical, or other GMP-regulated manufacturing environment
• Working knowledge of GMP and data integrity principles (ALCOA+)
• Experience with validation and qualification activities within pharmaceutical manufacturing
• Knowledge of supporting process validation, including mixing validation, buffer hold time, microbial hold time, or sterilization qualification
• Experience writing and reviewing validation protocols, reports, and technical documentation
• Knowledge of pharmaceutical regulations and industry guidelines (FDA, EMA, WHO, ICH, ISO, ISPE, PDA)
• Strong planning, documentation, communication, and problem-solving skills
• Fluent English (written and spoken)

• Hands-on experience with mixing validation, microbial hold time, buffer hold time, or moist heat sterilization qualification
• Experience supporting process qualification or change control programs
• Experience with risk assessments, root cause investigations, and CAPA
• Lean, Six Sigma, or other continuous improvement methodology experience
• Knowledge of process optimization, benchmarking, and standardization initiatives
• Dutch language skills
• Strong stakeholder management and cross-functional collaboration skills
• Ability to manage multiple validation activities and priorities simultaneously

Start Date: ASAP
Contract Duration: 12 months (with possibility of extension)
Location: Leiden, Netherlands
Hours: 40 hours per week
Work Arrangement: On-site

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