Validation Services Laboratory Specialist

Responsibilities

• Perform microbiological and physiochemical testing of raw materials and components according to written validation protocols
• Conduct incoming inspection and testing of materials including vials, stoppers, and other components
• Operate and maintain analytical instruments such as ICP-MS, HR-MS, and GC-MS
• Manage raw material and component specifications and review Certificates of Analysis (CoA)
• Interpret test results, complete laboratory data, and submit records for final approval

Requirements

• Bachelor's degree or higher in a relevant scientific field
• Hands-on experience in raw material testing and the operation of analytical instruments
• Proficiency in understanding and communicating via English documentation
• For experienced candidates: 3–5 years of relevant experience and the ability to perform method validation independently

Preferred Qualifications

• Experience working within a GMP environment
• Experience supporting regulatory inspections from authorities such as MFDS, U.S. FDA, or EMA
• Ability to provide technical leadership and guidance to team members

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.