The Company
Join one of the world’s leading biopharmaceutical companies, dedicated to improving patient lives through innovation in biologic medicines. At the Leiden site, you’ll contribute to the production of high-quality drug substances in a highly regulated and technical environment.
About the Role
As a Senior Process Validation Engineer, you’ll lead validation activities across cleaning, mixing, sterilization, and holding processes. You’ll work within the MSAT team to drive compliance, process improvement, and support new technology deployment.
Key Responsibilities
• Lead and execute validation projects for supporting processes
• Ensure compliance with GMP, FDA, and EMA requirements
• Write, review, and approve validation documentation
• Collaborate with Quality, MSAT, and Engineering teams
• Support audit readiness and continuous improvement initiatives
Qualifications & Requirements
• Bachelor’s or Master’s in Science, Engineering, or Biotechnology
• 4+ years’ experience in process validation within (bio)pharma
• Knowledge of GMP, validation protocols, and risk management
• Strong communication and problem-solving skills
• Lean / Six Sigma experience is an advantage
Other Information
This is a full-time onsite role based in Leiden, offering a unique opportunity to work on cutting-edge bioprocess validation in a global organization.
Looking forward to speaking with you!
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.