About the RoleThe Scientist, GMP Microbiology supports the qualification and routine monitoring of critical utility systems (WFI, PW, clean steam, compressed air, and process gases) at the Lilly Medicine Foundry, ensuring they consistently meet microbiological, chemical, and particulate requirements. The role partners with Utilities, PT&E, Manufacturing, and Quality, serves as an escalation point for utility excursions, and supports root cause investigations in line with cGMP and ALCOA+.
What You'll Do- Build the Utility Monitoring Program: Develop sampling plans, point-of-use maps, and risk-based alert/action levels aligned with the contamination control strategy.
- Drive Qualification Readiness: Author, execute, and summarize protocols and reports for phased water and gas system qualification (USP, EP, JP, ISPE, Lilly GQS).
- Execute Routine Monitoring: Oversee utility sampling and testing (bioburden, endotoxin, TOC, conductivity, microbial ID, particulates, steam quality, gas testing) within hold times and aseptic technique.
- Turn Data into Insight: Trend results, identify adverse trends early, and prepare periodic trend and system review reports.
- Ensure Data Integrity: Support LIMS (MODA) configuration and review records, SOPs, and controlled documents to keep data audit-ready.
- Lead Investigations That Matter: Support deviation, OOS/OOT, excursion, CAPA, and change control activities with Utilities, PT&E, and Quality.
- Champion Inspection Readiness: Keep practices aligned with cGMP, FDA, EU GMP Annex 1, and USP /, and present utility data during audits and inspections.
- Build the Team: Train sampling personnel and coordinate contract lab partners, instilling a "Right First Time" culture.
Minimum Qualifications- BS or MS in Microbiology, Biology, Chemistry, or a related life science discipline.
- 3+ years of experience in GMP microbiology or utility monitoring, including water and/or process gas sampling and investigations/CAPA.
- Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills and Preferences- Greenfield or start-up GMP facility experience, including commissioning and qualification.
- Hands-on experience with WFI/PW, clean steam, compressed air, and nitrogen/process gas systems.
- Proficiency with LIMS/trending tools (LabVantage, MODA,) and quality systems (Veeva Vault).
- Knowledge of microbial identification (MALDI-TOF, Vitek) and sterile, biologics, or genetic medicine operations.
Additional Information- Location: Initial location at Parkwood West, Carmel, IN, with occasional work at Lilly Technology Center, Indianapolis. Permanent location at the Lilly Medicine Foundry in Lebanon, IN.
- Travel: Less than 10% domestic
- Regular work in cleanroom and utility areas (ISO 5-8 / Grade A-D) requiring gowning per SOP.
- May require occasional off-hours or weekend support during startup and qualification.
- Physical requirements include standing for extended periods, walking throughout the facility, and gowning.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$66,000 - $171,600
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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