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
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.
We help our customers simplify progress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are part of the solution in the fight against diseases worldwide.
With innovative laboratory instruments and consumables, the Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes.
The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically.
Based in Göttingen, Germany, Sartorius also has a strong global reach with more than 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.
In 2024, Sartorius generated sales revenue of around 3.4 billion euros. Currently, more than 13,500 employees from around 110 nations are working for customers around the globe.
Join our team, partner or collaborate with us.
