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
• Perform process setup and qualification activities
• Manufacture and purify plasmid DNA (pDNA)
• Operate microbial cell culture and fermentation processes
• Prepare GMP documentation and maintain batch production records
• Support technology transfer (Tech Transfer) and troubleshooting activities

Requirements

• Bachelor's degree or higher in a relevant field
• Minimum 5 years of relevant laboratory or manufacturing experience
• Proficiency in understanding English documentation
• Strong English communication skills

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
• Direct experience in microbial cell culture and pDNA manufacturing processes

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.