Performs end-to-end quality activities across manufacturing processes, starting from equipment URS review through validation/qualification, PPQ, and in-process control, to support stable production.
The Quality Efficiency Professional will be responsible for designing and continuous improving of the core processes in quality management and the strategic assurance of quality-related method standards in projects and daily business. The holder of this position will focus is on the further development, implementation and training of quality methods.
Main Responsibilities & Tasks:
- Collaborate with process owners to establish Qualification and Validation strategies across the full lifecycle of equipment and manufacturing processes (URS, DQ, FAT, IQ, OQ, PQ, PPQ), ensuring compliance with requirements and regulations.
- Conduct and document risk assessments for systems, processes, and products using risk‑management tools such as FMEA and Impact Assessment.
- Ensure consistency and traceability across URS, functional analysis, FMEA, Control Strategy, and all Qualification/Validation deliverables.
- Develop and maintain the Validation Master Plan (VMP), ensuring alignment with overall project validation strategies.
- Manage documentation and records related to Commissioning, Qualification, and Validation, ensuring compliance, integrity, and completeness.
- Review and approve Qualification/Validation results, including Process Performance Qualification (PPQ), and perform data‑driven suitability assessments.
- Establish and implement in‑process control (IPC) strategies and inspection criteria to ensure stable operation of manufacturing processes.
Interfaces
- Local: Operation, Engineering etc.
- Global: Occasionally this person needs to contact equivalent scope of other Sartorius site people mainly located in France, German, US and China.
Qualification & Skills:
- Bachelor’s degree in engineering related.
- Min. 5 years of experience in equipment and process Qualification/Validation (URS–PPQ).
- Proven experience in VMP development, documentation traceability management, and establishing/evaluating IPC strategies for process stability.
- English communication capability
- Excellence communication skills to facilitate cross functional organization
- Work experience work in or with multinational healthcare industry
- Familiar with tube cutting, film welding/sealing (ultrasonic, impulse, thermal), press, leak testing and assembly process.
- Experienced with eQMS and SAP based work environment
- Analytical ability, data‑driven decisions, cross‑functional collaboration, and problem‑solving.
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
