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Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Scientist - Sterility Assurance - Technical Services/Manufacturing Science - **Company:** Eli Lilly - **Location:** Alzey, Germany - **Contract:** Permanent contract - **Skills:** Airflow, Data Analysis, Technical Data Management Systems - **Published:** July 31, 2026 - **Apply:** https://de.indeed.com/viewjob?jk=0786dd77695fa80a ## About the Role * 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 Englisch (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. ## Description 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.. ## Related Videos - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Why you shouldn’t build a microservice architecture ](https://www.wearedevelopers.com/videos/261-why-you-shouldn-t-build-a-microservice-architecture) - [From Messy Queries to Scalable Systems - How Data Engineering actually works](https://www.wearedevelopers.com/videos/100203-from-messy-queries-to-scalable-systems-how-data-engineering-actually-works) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [More efficient software for more efficient microchips](https://www.wearedevelopers.com/videos/1164-more-efficient-software-for-more-efficient-microchips) ## Related Articles - [Best Companies to Work For in Germany: Top 25 Companies in 2023 ](https://www.wearedevelopers.com/magazine/33-best-companies-to-work-for-in-germany-top-25-companies-in-2023) - [Welcome to Switzerland](https://www.wearedevelopers.com/magazine/4-welcome-to-switzerland) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [The Most Popular IT Jobs on the Market](https://www.wearedevelopers.com/magazine/376-the-most-popular-it-jobs-on-the-market) - [Best Companies to Work For in Berlin: Top 14 Companies in 2023 ](https://www.wearedevelopers.com/magazine/188-best-companies-to-work-for-in-berlin-top-14-companies-in-2023) - [Data Analyst Salary Germany](https://www.wearedevelopers.com/magazine/277-data-analyst-salary-germany)