QC Engineer

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