Validation Services Laboratory Specialist

Responsibilities

• Perform microbiological and physiochemical tests according to written validation protocols.
• Execute virus and mycoplasma sterility testing and manage associated documentation.
• Conduct qPCR assays, including PCR design, optimization, and sequencing assays.
• Support analytical method validation activities and prepare GMP documentation.
• Perform testing for manufacturing water systems, including WFI (Water for Injection).
• Conduct endotoxin and microbial limit testing and prepare trend reports.
• Interpret laboratory results, review data, and submit records for final approval.

Requirements

• Bachelor's degree or higher in a relevant scientific field.
• Knowledge in microbiology and/or cell culture.
• Proficiency in understanding and communicating via English documentation.
• Up to 3 years of relevant laboratory experience (entry-level candidates are welcome).

Preferred Qualifications

• Experience working within a GMP environment.
• Hands-on experience with PCR design and molecular biological analysis.
• Experience in environmental monitoring and sampling within a GMP manufacturing facility.
• Experience supporting regulatory inspections (e.g., MFDS, U.S. FDA, or EMA).
• Experience in setting up new GMP manufacturing facilities and performing qualification activities.

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.