Project Manager Validation Services

Responsibilities

• Manage Pharma and Bioprocess Validation Projects, including filters, bags, and other single-use components, for the local market.
• Coordinate validation projects in a timely manner according to agreed test scenarios and regulatory requirements (FDA, EMA, WHO).
• Provide technical consultancy and risk assessments based on global validation philosophies and harmonized test methods.
• Prepare quotes for various test scenarios and scopes.
• Prepare, review, and approve scientific and technical validation documents, including protocols and reports, in English.
• Promote validation services through workshops, webinars, and customer visits to support business growth.
• Perform regulatory surveillance on topics such as leachables/extractables, single-use system validation, and analytical methods.

Requirements

• 5-10 years of experience in Validation Services, Filtration, or the life science industry.
• Proven experience supporting single-use bioprocess validation projects in an advisory or hands-on capacity.
• Strong knowledge of Extractables/Leachables concepts and related analytical methods (e.g., HPLC-UV, GC-MS, LC-MS).
• Deep understanding of drug manufacturing processes and pharmaceutical regulatory requirements (FDA, EMA, WHO).
• Familiarity with GMP and GDP (Good Documentation Practices).
• Experience in project management and working effectively within a global team environment.

About the Company

Sartorius is 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.