Principal Scientist Deviation Management Lilly Medicine Foundry
Eli Lilly and Company
August 30, 2026
On-site
Indianapolis, IN
Operations
The Principal Scientist – Deviation Management leads deviation and out-of-specification (OOS) investigations, root cause analysis, CAPA development, and change control for Analytical GMP Laboratories (AGL) at the Lilly Medicine Foundry.
Key Responsibilities
- Lead deviation and OOS investigations (Minor, Major, Critical) using 5-Why, fishbone/Ishikawa, fault tree, and Is/Is-Not to determine true root cause.
- Author and review deviation reports, investigation protocols, and CAPA plans meeting data integrity (ALCOA+) standards and regulatory expectations.
- Draft risk-appropriate, measurable CAPA plans linked to verified root causes; author change control records assessing impact to validated processes, equipment, and systems.
- Perform hands-on troubleshooting and confirmatory testing; partner with QA/SMEs/stakeholders from assignment through closure; may lead Deviation Review Board meetings.
- Champion Analytical Compliance Excellence (ACE) quality priorities; support audit/inspection readiness.
- Drive process improvement using deviation metric analysis; support data integrity and training.
- Lead cross-functional trend analysis of investigations/deviation metrics; track items to closure and escalate at-risk records.
- Mentor junior investigators/analytical staff on root cause analysis and quality impact evaluation.
- Collaborate with Manufacturing, QA, Analytical/QC, Engineering, AGL branch leads, and external labs to verify corrective actions and confirm CAPA effectiveness.
Basic Qualifications
- BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology, or related field.
- BS + 6+ years or MS + 3+ years GMP manufacturing/quality/laboratory experience including deviation/OOS investigations, root cause analysis, and CAPA.
- Experience authoring investigation protocols, technical reports, and CAPA plans in a regulated environment.
- Authorized to work in the United States full-time (no visa sponsorship).
Additional Skills & Preferences
- ICH, FDA 21 CFR Parts 210/211, cGMP/data integrity (ALCOA+); electronic QMS (e.g., TrackWise, Veeva QMS) and lab documentation.
- Strong structured root cause analysis, technical writing, and troubleshooting on GMP equipment/analytical instrumentation.
- Change control, QRM (e.g., FMEA), validated systems risk/impact assessment, and understanding lot association.
- Leadership and mentoring; support regulatory inspections/audits.
Location/Work Information
- Indianapolis (initial) and Lebanon, IN (permanent). Travel 0–10%. First shift; occasional coverage. Ability to work in gowned GMP lab/manufacturing environment.
Benefits (explicitly stated)
- Anticipated wage: $65,250–$169,400; potential company bonus; eligibility for comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.
Key Responsibilities
- Lead deviation and OOS investigations (Minor, Major, Critical) using 5-Why, fishbone/Ishikawa, fault tree, and Is/Is-Not to determine true root cause.
- Author and review deviation reports, investigation protocols, and CAPA plans meeting data integrity (ALCOA+) standards and regulatory expectations.
- Draft risk-appropriate, measurable CAPA plans linked to verified root causes; author change control records assessing impact to validated processes, equipment, and systems.
- Perform hands-on troubleshooting and confirmatory testing; partner with QA/SMEs/stakeholders from assignment through closure; may lead Deviation Review Board meetings.
- Champion Analytical Compliance Excellence (ACE) quality priorities; support audit/inspection readiness.
- Drive process improvement using deviation metric analysis; support data integrity and training.
- Lead cross-functional trend analysis of investigations/deviation metrics; track items to closure and escalate at-risk records.
- Mentor junior investigators/analytical staff on root cause analysis and quality impact evaluation.
- Collaborate with Manufacturing, QA, Analytical/QC, Engineering, AGL branch leads, and external labs to verify corrective actions and confirm CAPA effectiveness.
Basic Qualifications
- BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology, or related field.
- BS + 6+ years or MS + 3+ years GMP manufacturing/quality/laboratory experience including deviation/OOS investigations, root cause analysis, and CAPA.
- Experience authoring investigation protocols, technical reports, and CAPA plans in a regulated environment.
- Authorized to work in the United States full-time (no visa sponsorship).
Additional Skills & Preferences
- ICH, FDA 21 CFR Parts 210/211, cGMP/data integrity (ALCOA+); electronic QMS (e.g., TrackWise, Veeva QMS) and lab documentation.
- Strong structured root cause analysis, technical writing, and troubleshooting on GMP equipment/analytical instrumentation.
- Change control, QRM (e.g., FMEA), validated systems risk/impact assessment, and understanding lot association.
- Leadership and mentoring; support regulatory inspections/audits.
Location/Work Information
- Indianapolis (initial) and Lebanon, IN (permanent). Travel 0–10%. First shift; occasional coverage. Ability to work in gowned GMP lab/manufacturing environment.
Benefits (explicitly stated)
- Anticipated wage: $65,250–$169,400; potential company bonus; eligibility for comprehensive benefits including 401(k), medical/dental/vision, flexible benefits, life insurance, time off/leave, and well-being benefits.
Application Instructions
- If you require accommodation to submit a resume, complete the workplace accommodation request form: https://careers.lilly.com/us/en/workplace-accommodation.