Sartorius

Validation Services Laboratory Specialist

Sartorius  •  Republic of Korea (Onsite)  •  14 days ago
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Job Description

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

Sartorius

About Sartorius

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.

Industry
Biotech & Life Sciences
Company Size
5,001-10,000 employees
Headquarters
Göttingen, DE
Year Founded
1870
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