The Validation Services Laboratory Specialist will be responsible for performing microbiological and physiochemical tests according to written validation protocols. The position holder will interpret results, complete and review laboratory data, and submit records for final approval.
Main Responsibilities & Tasks:
- Provide qualification / validation quality / compliance support compliant with laboratory safety procedures and requirements of Sartorius Stedim
- Perform viability, bacterial challenge, product specific integrity and chemical compatibility tests according to Sartorius standard operating procedures and approved validation protocols
- Perform in-coming material testing
- Prepare strains, culture media, test solutions and reagents necessary for the performance of all laboratory tests
- Handle biological indicators, cultures, chemicals and test solutions according to government regulations and company standard operating procedures
- Complete laboratory data form, interpret results and review
- Inform laboratory manager of any deviations related to validation protocol execution
- Initiate and complete any investigations related to deviation of validation protocols or out of specification results
- Perform necessary cleaning and sanitizing of the laboratory and equipment after testing
- Check daily monitoring data of laboratory environment and temperature controlled equipment
- Perform inventory control of consumables and standard reagents to ensure the safety stock
- Perform qualification, calibration and maintenance of relevant equipment or devices
- Review validation protocols and validation reports
- Assist in maintenance of standard operating procedures, including writing and revising
Qualification & Skills:
- Academic or technical degree in sciences / engineering or similar
- Minimum 3-5 years of work experience including filtration knowledge
- Experience in the pharmaceutical industry is a plus
- Good understanding of GMP requirements
- Familiar with microbiological 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