Site Microbiologist (m/w/d)

Site Microbiologist (m/w/d)

Location Alzey, Rhineland-Palatinate, Germany Category Manufacturing/Quality Job Type Full Time Regular Job Id R-97740

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.

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."

Site Microbiologist (Responsible Scientist) (m/w/d)

What tasks await you?

• Method

Validation: Provides expert oversight of method transfers and validations within the QC Microbiology Laboratory in accordance with GMP, USP/Ph.

Eur., and Lilly Global Lab Quality Standards.

Applies expertise in compendial methods for sterility, bioburden, and endotoxin testing.

Demonstrates the ability to further develop knowledge of rapid microbial methods.

Understands the analytical instrument validation lifecycle, from user requirements through qualification to instrument release.

• Water

Systems: Acts as the microbiological SME for water systems (e. g., WFI, PW, clean steam, and source water).

Provides guidance to engineering and sterile manufacturing on water sampling plans during water system qualification and routine monitoring.

Interprets water system results from bioburden, endotoxin, and microbiological identity testing, and takes action based on the results to drive system and process improvement.

• Environmental

Monitoring: Acts as the microbiological SME for environmental monitoring, including viable and non-viable sampling, in Grade A to Grade D areas across manufacturing and QC areas.

Provides guidance on implementing environmental monitoring programs in accordance with regulatory requirements.

Demonstrates an understanding of the overall contamination control strategy (CCS) for manufacturing and QC areas.

• Sterilization / Depyrogenation Equipment and
• Cleaning

Validation: Understands manufacturing equipment and processes such as autoclaves, isolators, dry heat tunnels, and CIP/SIP processes.

Has an in-depth understanding of the associated microbiological samples, such as biological indicators, endotoxin indicators, rinse samples, and swab samples.

Demonstrates an understanding of testing and interpreting results.

• Audits: Acts as a front-room SME, discussing topics directly with regulatory bodies. Acts as a microbiology SME during audit tours and audit responses.
• Investigations: Leads GMP investigations, including OOS/OOT, deviations, and atypical results, using recognized root cause analysis methodologies such as 5-Why and Ishikawa/Fishbone.

Draws sound technical conclusions and recommends corrective and preventive actions.

• Projects / Workload

Projections: Acts as the QC Microbiology representative for the above-named topics and forecasts QC Microbiology workload.

Performs technical review, interpretation, and release of raw material, in-process, and finished product data, and contributes to annual product reviews and process validations.

Provides technical training and mentors analysts through a formal process.

Contributes to the development and implementation of Global Lab Quality Standards.

What do you need to convince us?

• Education

Level: Master’s degree or Bachelor’s degree in a science or engineering-related discipline, with extensive relevant work experience in topics/areas such as QC Laboratories, manufacturing areas, utility systems, environmental monitoring and method validation.

• Experience: 7–10 years of demonstrated relevant experience in a GMP Microbiology Laboratory, sterile manufacturing areas, and utility systems.
• Prior work across the full analytical method lifecycle (development, verification, transfer, validation, and remediation) for microbiological test methods (Bioburden, Endotoxin, Sterility)
• Fluent in English & good German

Additional Skills/ Preferences

• Demonstrated strong problem-solving skills, with preferred training and proficiency in Root Cause Analysis methodology.
• Demonstrated strong interpersonal and communication skills, with the ability to interact effectively with business partners and auditors.
• Proven ability to focus on continuous improvement.
• Deep understanding of compliance requirements and regulatory expectations, including GMP, USP, Ph. Eur., and EU GMP Annex 1.

Additional Information

• Primary location is Alzey, Germany
• Ability to travel (approximately 10-20 %)
• On-site presence required

What can you look forward to with us?

• Pioneering spirit: Become part of a team of specialized professionals that will grow to up to 1,000 colleagues over the next three years.
• Innovation: You will work in a medical high-tech production facility equipped with the most advanced technology.
• Creative freedom: From the beginning, you will have the freedom to contribute your ideas and implement them in cross-functional teams.
• Development: We value the individual career development of our employees and ensure fair access to professional development worldwide through our "Corporate Lilly University."
• Financial benefits: In addition to your attractive salary, we offer you the option of an excellent company pension plan and other individual benefits.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions.

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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