Scientist – Sterility Assurance - Technical Services/Manufacturing Science (m/w/d)
Eli Lilly
- Location
- Alzey, Rhineland-Palatinate, Germany
- Employment
- Full Time
- Work model
- On-Site
- Level
- Mid
- Posted
- 12h ago
Skills
About this role
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Scientist – Sterility Assurance – Technical Services / Manufacturing Science (m/w/d) At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. At Lilly in Germany, we are currently planning and building a high-tech production facility in Alzey (Rhineland-Palatinate), which will expand our production of injectable drugs from 2027 and employ up to 1,000 specialists. To make the most of our innovative production site, we are looking for motivated reinforcements who, together with us, will ensure the supply of Lilly medicines in Germany, Europe, and worldwide, in line with the three Lilly values of "Excellence," "Integrity," and "Respect for People."" Responsibilities The Sterility Assurance Scientist is a technical role responsible for supporting the development, implementation, maintenance, and continuous improvement of the site's sterility assurance programs. This position provides technical expertise in environmental monitoring, contamination control, aseptic process simulations, gowning and aseptic practices, cleaning and sanitization strategies, disinfectant efficacy, and microbiological risk management. The role collaborates cross-functionally with Operations, Quality, Engineering, Validation, and Technical Services to ensure robust contamination control strategies and compliance with regulatory requirements and internal quality standards. Depending on business needs and expertise, the position may lead initiatives, provide technical oversight, or contribute as a subject matter expert to sterility assurance programs and projects. Key Objectives / Deliverables Ensure effective implementation, maintenance, and continuous improvement of sterility assurance programs within manufacturing operations. Lead, support, or provide technical oversight for activities related to sterility assurance programs, including Airflow Pattern Testing, Environmental Monitoring Performance Qualifications, Aseptic Process Simulations, Cleaning, Sanitization and Disinfection, Gowning within GMP Areas, Aseptic Processing Techniques, and Contamination Control. Support the development, implementation, monitoring, and continuous improvement of contamination control strategies and associated facility monitoring programs. Provide technical expertise related to contamination control, cleaning and sanitization programs, disinfectant efficacy strategies, cleanroom gowning, and aseptic processing practices. Support, coordinate, or provide technical oversight for Environmental Monitoring (EM) and Aseptic Process Simulation (APS) programs. Author, review, maintain, and support execution of protocols, reports, procedures, qualification documents, risk assessments, and other technical documentation related to sterility assurance programs. Analyze, interpret, and trend microbiological, environmental