Principal Scientist Deviation Management Lilly Medicine Foundry
Eli Lilly and Company
August 08, 2026
On-site
Lebanon, IN
Operations
Principal Scientist – Deviation Management
Key Responsibilities
- Lead deviation and out-of-specification (OOS) investigations (Minor, Major, Critical) using structured root cause analysis (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not).
- Author and review deviation reports, investigation protocols, and CAPA plans aligned with data integrity (ALCOA+) and regulatory expectations.
- Draft risk-appropriate, measurable CAPAs linked to verified root causes; author change control records assessing impact to validated processes/equipment/systems.
- Perform hands-on troubleshooting and confirmatory testing; partner with QA/SMEs/stakeholders from assignment through closure and may lead Deviation Review Board meetings.
- Serve as an ACE thought leader; support audit/inspection readiness; drive improvements using deviation metrics.
- Track trends to closure; escalate at-risk items.
- Mentor junior investigators; serve as a GMP compliance/investigation strategy resource.
- Collaborate across Manufacturing, Quality Assurance, Analytical/QC, Engineering, and branch leads to verify corrective actions and CAPA effectiveness.
Basic Qualifications
- BS in Chemistry/Biochemistry/Engineering/Pharmaceutical Sciences/Biology (or related).
- BS 6+ years or MS 3+ years GMP manufacturing/quality/lab experience, including deviation/OOS, root cause, and CAPA.
- Experience authoring investigation protocols, technical reports, and CAPA plans.
- US work authorization required (no visa sponsorship).
Additional Skills/Preferences
- Working knowledge of ICH and FDA 21 CFR Parts 210/211; cGMP/data integrity (ALCOA+).
- Experience with QMS (e.g., TrackWise/Veeva) and lab/GMP documentation systems.
- Strong technical writing; hands-on troubleshooting on equipment/instrumentation.
- Change control/risk/impact assessment experience; familiarity with QRM tools (e.g., FMEA).
Other Information
- Location: Lilly Technology Center (Indianapolis), permanent at Lilly Medicine Foundry (Lebanon, IN).
- Travel 0–10%; first shift, occasional off-shift/weekend/holiday coverage.
- GMP environment work; PPE; stand extended periods; handle hazardous materials/solvents as needed.
Benefits
- Eligible for company bonus and comprehensive benefit program (medical/dental/vision, 401(k), pension, vacation, life insurance, time off/leave, well-being benefits).
Key Responsibilities
- Lead deviation and out-of-specification (OOS) investigations (Minor, Major, Critical) using structured root cause analysis (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not).
- Author and review deviation reports, investigation protocols, and CAPA plans aligned with data integrity (ALCOA+) and regulatory expectations.
- Draft risk-appropriate, measurable CAPAs linked to verified root causes; author change control records assessing impact to validated processes/equipment/systems.
- Perform hands-on troubleshooting and confirmatory testing; partner with QA/SMEs/stakeholders from assignment through closure and may lead Deviation Review Board meetings.
- Serve as an ACE thought leader; support audit/inspection readiness; drive improvements using deviation metrics.
- Track trends to closure; escalate at-risk items.
- Mentor junior investigators; serve as a GMP compliance/investigation strategy resource.
- Collaborate across Manufacturing, Quality Assurance, Analytical/QC, Engineering, and branch leads to verify corrective actions and CAPA effectiveness.
Basic Qualifications
- BS in Chemistry/Biochemistry/Engineering/Pharmaceutical Sciences/Biology (or related).
- BS 6+ years or MS 3+ years GMP manufacturing/quality/lab experience, including deviation/OOS, root cause, and CAPA.
- Experience authoring investigation protocols, technical reports, and CAPA plans.
- US work authorization required (no visa sponsorship).
Additional Skills/Preferences
- Working knowledge of ICH and FDA 21 CFR Parts 210/211; cGMP/data integrity (ALCOA+).
- Experience with QMS (e.g., TrackWise/Veeva) and lab/GMP documentation systems.
- Strong technical writing; hands-on troubleshooting on equipment/instrumentation.
- Change control/risk/impact assessment experience; familiarity with QRM tools (e.g., FMEA).
Other Information
- Location: Lilly Technology Center (Indianapolis), permanent at Lilly Medicine Foundry (Lebanon, IN).
- Travel 0–10%; first shift, occasional off-shift/weekend/holiday coverage.
- GMP environment work; PPE; stand extended periods; handle hazardous materials/solvents as needed.
Benefits
- Eligible for company bonus and comprehensive benefit program (medical/dental/vision, 401(k), pension, vacation, life insurance, time off/leave, well-being benefits).