Quality control test engineer/specialist responsible for detail design lab facility, instrument.
Primary contact of quality control test related with material, product , and process suitability confirmation.
Expert on microbiology, chemical and physical test of subjected material.
Responsibilities:
- Review list of material, product, test method, instrument list to design intended scope of the work.
- Review and decide right spec of instrument to be procured. Develop test method if needed.
- Communicate with contract lab, external lab for tech transfer.
- Participate QC instrument, process equipment, and other facility & utility qualification process by providing service related with test plan, test execution and report with documentation.
- Design and standardize sampling scheme, test scheme and procedures as SOP/WI.
- Contribute process improvement.
- Set strategy for clean room qualification & monitoring plan for non-viable and viable particles based on risk analysis of product, production environment, and process aligned with sending site knowledge.
- Plan for lab project to be aligned with construction schedule and clean utility IOPQ.
- Prepare local procedure for clean environment monitoring & control.
- Prepare local procedure for product monitoring & control for viable and non-viable particles.
Interfaces:
- Production site Quality, Local Process Engineering, Local Construction project engineering, Procurement
Qualifications & Requirements:
- Minimum of a Bachelor’s degree in Microbiology, or related to life science
- Min. 10 years’ well-proven work experiences in microbiology QC/QA.
- Experienced aseptic production related quality control
- Strong risk assessment knowledge
- Strong problem-solving methodologies knowledge
- Skill to drive objectives or persuade stakeholders based on scientific/regulatory rational.
- Project management experience: implement, master and track timing plan, key performance indicators and action plan.
- English communication capability
- Experienced with group of people management skill
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
Top Skills
What We Do
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing.
We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide.
With innovative laboratory instruments and consumables, the our 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 around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies.
In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe.
Join our team, partner or collaborate with us.
