Validation Services Laboratory Specialist

Responsibilities

• Perform microbiological and physiochemical tests according to written validation protocols
• Interpret results, complete and review laboratory data, and submit records for final approval
• Execute animal cell culture and cell banking/filling operations (MCB/WCB)
• Prepare and review GMP documentation and manage manufacturing schedules and materials
• Perform process setup, qualification activities, and manufacture cell therapy products
• Support technology transfer (Tech Transfer) and troubleshooting activities

Requirements

• Bachelor's degree or higher in a relevant scientific field
• Proficiency in English for understanding documentation and effective communication
• For Advanced Biopharmaceuticals roles: Minimum 5 years of relevant experience
• Strong understanding of GMP documentation and cell culture operations

Preferred Qualifications

• Experience supporting inspections by regulatory authorities such as MFDS, U.S. FDA, and EMA
• Experience in establishing new manufacturing facilities and performing qualification activities
• Expertise in cell line culture, purification processes, and cell therapy product manufacturing

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.