Scientist – Sterility Assurance – Technical Services/Manufacturing Science (m/w/d) Full-time

Scientist – Sterility Assurance – Technical Services / Manufacturing Science

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 monitoring, aseptic process simulation, and manufacturing data to identify process variability, adverse trends, and opportunities for continuous improvement.
• Apply sterility assurance and contamination control risk management principles to evaluate manufacturing processes and associated controls with respect to microbial, endotoxin, and particulate contamination risks.
• Support environmental isolate identification, characterization, and culture management activities as required.
• Ensure Environmental Monitoring and Aseptic Process Simulation programs remain compliant with applicable regulatory requirements, quality standards, and site procedures.
• Lead or provide technical support for investigations related to contamination events, environmental monitoring excursions, aseptic process simulation outcomes, and other sterility assurance topics.
• Participate in and provide technical expertise during internal audits, external audits, regulatory inspections, and quality assessments.
• Develop, review, and implement corrective and preventive actions arising from investigations, audits, inspections, monitoring programs, and continuous improvement initiatives.
• Collaborate effectively with Operations, Quality, Engineering, Validation, Microbiology, and other cross-functional teams to achieve business and quality objectives.
• Contribute to site projects, technology transfers, inspection readiness activities, operational improvements, and strategic sterility assurance initiatives.
• Provide technical guidance and share knowledge to strengthen sterility assurance capabilities across the organization.

Basic Qualifications

• Bachelor's or Master's Degree in Microbiology, Biology, Biochemistry, Biochemical Engineering, Chemical Engineering, Pharmaceutical Sciences, or a related scientific discipline.
• Relevant experience in pharmaceutical manufacturing, microbiology, sterility assurance, environmental monitoring, technical services, validation, quality assurance, or related areas within a cGMP-regulated environment.
• Demonstrated understanding of scientific principles associated with the manufacture of sterile and parenteral drug products.
• Knowledge of contamination control principles, microbiological risk management, and aseptic processing practices.
• Experience supporting technical investigations, risk assessments, and quality systems.

Additional Skills / Preferences

• Strong understanding of sterile manufacturing processes and contamination control strategies.
• Knowledge of pharmaceutical microbiology, including microbiological media, enumeration techniques, microorganism isolation, and identification.
• Experience with Environmental Monitoring and/or Aseptic Process Simulation programs.
• Experience with data analysis, statistical evaluation, and trend reporting.
• Strong interpersonal skills and ability to work effectively within cross-functional teams.
• Strong organizational, prioritization, and self-management skills.
• Effective verbal and written communication skills in English (German is a plus).
• Ability to influence decisions through technical expertise and scientific rationale.
• Continuous improvement mindset with a focus on quality, compliance, and operational excellence.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.