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 medicines from 2027 and employ up to 1,000 specialists. In order to make the best possible use of the potential of our innovative production site, we are looking for motivated reinforcement who would like to work with us on an equal footing and under the three Lilly values of "excellence", "integrity" and "respect for people" to ensure the supply of patients with Lilly medicines in Germany, Europe and worldwide.
Become part of our Lilly team in Alzey and start as soon as possible as:
Quality Control Microbiologist (m/w/d) - 18-Month Duration
What tasks await you?
This contract role supports the Alzey site in ensuring microbiological quality and compliance during the establishment and operational phases of the facility. The position is critical to building a robust Quality Control Microbiology function, contributing to site readiness, regulatory compliance, and the successful transfer of manufacturing operations. The role holder will perform routine and investigational microbiological testing, environmental monitoring activities, and support laboratory setup, qualification activities, and process validation in alignment with cGMP requirements and company standards.
Key Responsibilities
Perform routine microbiological testing including sterility, endotoxin, bioburden, biological indicators, microbial identification, and method suitability testing on raw materials, in-process samples, finished products, water, and gases.
Execute environmental monitoring (EM) activities including viable and non-viable air sampling, surface monitoring, personnel monitoring, water sampling, and compressed gas testing in classified cleanroom areas.
Support qualification and validation activities including Environmental Monitoring Performance Qualification (EMPQ), Pre-Approval Readiness (PAR) cycles, Clean Utilities PQ, and CIP/SIP validation protocols.
Operate, maintain, and calibrate laboratory equipment and EM instruments including air samplers, particle counters, incubators, autoclaves, and analytical instruments in compliance with maintenance schedules.
Prepare and maintain microbial stock cultures, growth media, reagents, and consumables; manage laboratory inventory and perform material qualifications.
Execute accurate documentation in LIMS and electronic systems; ensure data integrity in compliance with ALCOA+ principles and good documentation practices (GDP).
Identify, investigate, and document deviations, out-of-specification (OOS) results, and environmental excursions; participate in root cause analysis (RCA) and implement corrective and preventive actions (CAPA).
Create, review, and revise standard operating procedures (SOPs), protocols, work instructions, trend reports, and technical documentation to support site operations and regulatory compliance.
Coordinate external laboratory testing including sample submission, result review, and oversight of contract laboratory activities to ensure quality and compliance.
Qualifications
Bachelor's or Master's degree in Microbiology, Biology, Biochemistry, or related life sciences discipline.
3–5 years of hands-on experience in a GMP-regulated microbiology laboratory within the pharmaceutical or biotechnology industry.
Technical Skills:
Proficiency in microbiological testing techniques, aseptic practices, and environmental monitoring protocols.
Familiarity with laboratory information management systems (LIMS) such as MODA, SmartLab, and quality systems such as TrackWise.
Knowledge of cleanroom operations, contamination control strategies, and cGMP regulatory requirements (FDA, EMA, EU GMP Annex 1).
Understanding of ALCOA+ data integrity principles and good documentation practices.
Language and Soft Skills:
Proficiency in both German and English (written and oral communication).
Strong attention to detail with excellent problem-solving and analytical skills.
Ability to work independently and collaboratively in cross-functional teams.
Flexibility to work shifts, weekends, and overtime during critical operational phases.
What you can expect from us:
Shaping a new beginning: Become part of the founding team of a new high-tech production facility.
Define culture: Shape the quality culture from the very beginning and set standards for our future processes.
Working with meaning: Your work has a direct impact on the delivery of life-changing medicines.
Daily innovation: Work with state-of-the-art technologies in a dynamic, future-oriented environment.
Personal and professional growth: We promote your development. Through our "Corporate Lilly University" you will have access to a wide range of continuing education opportunities and can advance your career.
Attractive services: Benefit from a competitive salary, an excellent company pension plan and numerous individual benefits to support your well-being and financial security
Have we aroused your interest? Then please apply online with your complete application documents via our applicant portal.
We look forward to receiving your application!
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 (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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.
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