Validation Services Laboratory Specialist

Responsibilities

• Perform pharmaceutical and biopharmaceutical analytical tests following written validation protocols and GLP procedures.
• Support Extractables & Leachables (E&L) testing and analytical method development.
• Analyze data from analytical instruments including HPLC, GC-MS, and ICP-MS.
• Manage the full lifecycle of validation and qualification activities.
• Prepare and review SOPs, validation protocols, test plans, and technical reports.
• Conduct cell-based assays and qPCR-based analyses related to virus clearance.
• Perform testing related to chromatography-based purification processes.
• Collaborate with customers and global cross-functional teams through technical discussions.

Requirements

• Master's degree or higher in Life Sciences, Microbiology, Biotechnology, Chemistry, Analytical Chemistry, or a related field.
• Up to 5 years of relevant experience (entry-level candidates are welcome).
• Strong understanding of GLP (Good Laboratory Practice) environments.
• Ability to understand technical documentation and communicate effectively in English.

Preferred Qualifications

• Experience in pharmaceutical purification processes or QC analysis.
• Experience with Method Validation and Method Transfer.
• Experience in non-targeted analysis using HPLC, GC-MS, and ICP-MS.
• Experience with mammalian cell culture and virus handling.
• Proficiency operating ÄKTA chromatography systems and related equipment.
• Understanding of Toxicological Risk Assessment and downstream purification 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.