Sterile Manufacturing Validation Lead

We are seeking an experienced Validation Team Leader to join our team. As a key member of our organization, you will be responsible for leading a team of validation engineers in the development and implementation of validation protocols.

The ideal candidate will have a strong background in engineering, preferably with a degree in chemical, biomedical, or pharmaceuticals. Additionally, they should have at least 3 years of experience in validating process equipment, particularly in sterile environments.

You will be expected to write and execute protocols and reports (IQ, OQ, PQ) for equipment, as well as take full responsibility for cleaning validation - planning, execution, and coordination with analytical laboratories.

• Lead a team of validation engineers in the development and implementation of validation protocols.
• Write and execute protocols and reports (IQ, OQ, PQ) for equipment.
• Take full responsibility for cleaning validation - planning, execution, and coordination with analytical laboratories.
• Plan and manage engineering projects while complying with GMP and FDA regulations.
• Manage tasks, prioritize, and monitor team schedules.
• Ongoing interface with QA, operations, maintenance, production, laboratories, and R&D departments.
• Support handling exceptions, risk analysis, and failure investigation.

• Bachelor's degree in engineering (chemical, biomedical, biotechnology, pharmaceuticals).
• At least 3 years of experience in validating process equipment - especially in a sterile environment.
• Deep familiarity with CIP/SIP cleaning processes including cleaning validation.
• Experience in writing protocols and IQ/OQ/PQ reports.
• Understanding of GMP regulations and regulatory requirements for sterile manufacturing systems.
• Management experience or leading teams/projects.
• Ability to work in a dynamic environment.

We are part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds who want to contribute to this goal and advance their careers in a dynamic global environment.

Our organization is committed to providing a collaborative and inclusive work environment where everyone feels valued and empowered to succeed.