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Senior Engineer

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Leiden, Zuid-Holland, Nederland SIRE® Life Sciences 🧬 Voltijd

Senior Engineer – Leiden, The Netherlands

About Our Client

Our client is a leading biopharmaceutical organization dedicated to developing and producing innovative biotherapeutic drug substances that improve patient lives worldwide. Their Leiden site is expanding its portfolio and continues to play a vital role in delivering high-quality, safe, and effective medicines.

About the Role

As a
Senior Engineer
, you will be part of the Manufacturing Science & Technology (MSAT) Supporting Process Validation (SPV) team. You'll take a lead role in validation activities for supporting processes, ensuring robust and compliant manufacturing systems. This position offers the opportunity to drive process improvements, implement new technologies, and contribute to the continuous growth of a world-class manufacturing site.

Key Responsibilities

  • Lead, plan, and execute validation activities, including cleaning validation, mixing validation, sterilization qualification, and holding time studies.
  • Define and support validation strategies and change control assessments.
  • Prepare, review, and approve validation protocols and reports.
  • Collaborate with project teams to ensure timely and compliant execution of validation tasks.
  • Coordinate with cross-functional stakeholders and escalate issues as needed.
  • Support audit and inspection readiness activities.
  • Ensure compliance with company quality, safety, and business policies.

Qualifications

  • Bachelor's or Master's degree in Science, Engineering, or a related technical field.
  • Minimum of 4 years' relevant experience in the (bio)pharmaceutical industry or equivalent academic background.
  • Strong communication, planning, and documentation skills.
  • Solid understanding of pharmaceutical regulatory requirements and validation standards (FDA, EMA, ICH, ASTM, ISO, ISPE, PDA).
  • Proven experience in process qualification and validation activities.

Preferred

  • Experience with Lean, Six Sigma, or other continuous improvement methodologies.

If you're passionate about process excellence, innovation, and making a difference in patients' lives, this is an excellent opportunity to join a growing and impactful organization.