As the Sterility Validation Quality Engineer, you will be responsible for sterility of the Single use solution products using basic skills and strong technical knowledge of appropriate standards, procedures, methods, techniques, as well as applicable current good manufacturing practice and state of the art.
Main Responsibilities & Tasks:
- Develop the strategy, implement and optimize validation of sterility as per state of the art and current applicable standards
- Establish and lead the plan and coordinate project at local site based on global process
- Support validation maintenance as per describe in the validation plan and procedures
- Train on local manufacturing sites
- Support customer audit and inspection
- Write and review Standard Operating Procedures (SOPs)
- Support ongoing process improvement endeavors
- Provide support for new internal and sponsored projects including reviewing protocols and reports
- Provide support in the management of OOS
- Provide data for sterilization validation for US DMF Type III submitted by Compliance Team
- In charge of sterilization suppliers qualification audit based on existing process
- Acts towards FMT objectives in terms of Compliance and Quality
- Has got a full autonomy to organize and execute her tasks, under the supervision of the Site Quality manager
- Develop testing, technical survey, best practices according to the regulations & state of the art
- Organize and conduct validation plan according to European and US Quality standards and internal documentation and Quality procedures
Qualification & Skills:
- Bachelor's degree in microbiology, biotechnology Engineering or related field
- Gamma irradiation, E-beam, X-ray sterilization process knowledge and practical experience is the must
- 5 years of relevant work experience, including 2+ years of experience in pharmaceutical or medical devices environment
- Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems
- Ability to quickly acquire organizational skills, including the ability to manage multiple processes and priorities effectively assess assigned task requirements to transversal, identify potential challenges, and communicate effectively to expedite the successful execution of assigned work
- Be a force of proposal within the framework of strategic approaches
- Perfect command of English
- Project participation experience related to facility qualification is a strongly preferred.
- Work experience work in or with multinational healthcare industry
- Experienced with eQMS and SAP based work environment
- Self-motivated, entrepreneurship, enjoying exploring new technology (IT tools)
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