Validation Services Laboratory Specialist

The Validation Services Laboratory Specialist will be responsible for performing pharmaceutical and biopharmaceutical analytical tests according to written validation protocols and GLP procedures. The position holder will interpret results, complete and review laboratory data, and support qualification, validation, and analytical activities for various biologics-related studies.

[Sterile Filter Validation]
* Supported Extractables & Leachables (E&L) testing and analytical method development.
* Analyzed data generated from analytical instruments including HPLC, GC-MS, and ICP-MS.
* Managed the full lifecycle of Validation and Qualification activities.
* Prepared and reviewed SOPs, validation protocols, test plans, and technical reports.
* Communicated technical information with customers and global cross-functional teams.
[Virus Clearance]
* Performed testing related to chromatography-based purification processes.
* Conducted Cell-based Assays and qPCR-based analyses.
* Planned, executed, and evaluated analytical method validation studies.
* Prepared and maintained GLP-compliant SOPs, study protocols, and reports.
* Supported GLP inspections and quality system compliance activities.
* Collaborated with customers and global teams through technical discussions and project communications.

Qualifications
* Master's degree or higher in Life Sciences, Microbiology, Biotechnology, Chemistry, Analytical Chemistry, or a related field
* Entry-level candidates or candidates with up to 5 years of relevant experience
* 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
* Understanding of GLP or other regulatory-based testing and quality environments
* Experience in writing SOPs and laboratory documentation
* Experience with Method Validation and Method Transfer

Preferred Experience – Analytical Testing
* Experience with Extractables & Leachables (E&L) studies
* Experience in non-targeted analysis using HPLC, GC-MS, and ICP-MS
* Understanding of Toxicological Risk Assessment
* Experience in analytical method development and new instrument setup/qualification

Preferred Experience – Biological Testing
* Experience with Mammalian Cell Culture and Virus Handling
* Understanding of downstream purification processes
* Experience operating ÄKTA chromatography systems and related equipment

About Sartorius 

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.

Join our global team and become part of the solution. We are looking forward to receiving your application. 
www.sartorius.com/careers