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.

he 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.

Main Responsibilities & Tasks:

Perform Filter Validation, Virus Clearance, Extractables & Leachables (E&L), and chromatography-related tests according to Sartorius standard operating procedures and approved validation protocols

Operate analytical instruments including HPLC, GC-MS, ICP-MS, qPCR, and related laboratory equipment

Prepare strains, culture media, test solutions, reagents, and cell culture materials necessary for laboratory testing

Handle biological indicators, cultures, chemicals, viral materials, and test solutions according to government regulations and company standard operating procedures

Complete laboratory data forms, interpret results, and review analytical data

Perform qualification, calibration, maintenance, and routine monitoring of relevant equipment and laboratory environments

Review validation protocols, study plans, SOPs, and validation reports

Assist in maintenance of standard operating procedures, including writing and revising documentation

Support Data Integrity and documentation management activities for regulatory compliance and inspections

Qualification & Skills:

• •Academic or technical degree in sciences / engineering or similar
• •Entry-level or up to 5 years of work experience
• •Experience in the pharmaceutical industry is a plus
• •Good understanding of GLP requirements
• •Familiar with analysis testing and operating related equipment
• •Self-sufficient, target oriented, well organized and self-motivated work style
• •Good communication and problem-solving skills
• •Experienced with project management and teamwork (ideally in a global environment)
• •Team and customer service orientated attitude
• •Proven software skills, e.g. Microsoft Office
• •Fluent in English

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