Principal Scientist Deviation Management Lilly Medicine Foundry
Eli Lilly and Company
August 30, 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 RCA methods (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not) to determine true root cause.
- Author/review deviation reports, investigation protocols, and CAPA plans meeting 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, and stakeholders through closure; may lead Deviation Review Board meetings.
- Serve as a thought leader on the Analytical Compliance Excellence (ACE) team; support audit/inspection readiness.
- Drive improvement using deviation metric analysis; lead trend analysis across investigations and CAPA/change control to closure with escalation of at-risk items.
- Mentor junior investigators/staff on RCA, technical writing, and quality impact evaluation.
Basic Qualifications
- BS in Chemistry/Biochemistry/Engineering/Pharma Sciences/Biology (or related).
- BS + 6+ years or MS + 3+ years GMP manufacturing/quality/lab experience including deviation/OOS, RCA, and CAPA.
- Experience authoring regulated investigation protocols, technical reports, and CAPA plans.
- Must be authorized to work in the U.S. (Lilly does not sponsor visas).
Preferred Skills
- Working knowledge of ICH, FDA (21 CFR Parts 210/211), and cGMP/data integrity (ALCOA+).
- Experience with TrackWise/Veeva QMS and GMP documentation/informatics platforms.
- Strong technical writing and troubleshooting on GMP equipment/analytical instrumentation; QRM/risk and change control experience; experience with inspections/audits.
Benefits (as stated)
- Eligibility for 401(k), pension, vacation; medical/dental/vision; flexible benefits; life insurance; certain time-off/leave; well-being benefits; eligible for company bonus.
Other Information
- Location: Lilly Technology Center (initial) then Lilly Medicine Foundry, Lebanon, IN. Travel 0–10%. First shift; occasional off-shift/weekend/holiday coverage.
Key Responsibilities
- Lead deviation and out-of-specification (OOS) investigations (Minor/Major/Critical) using structured RCA methods (5-Why, fishbone/Ishikawa, fault tree, Is/Is-Not) to determine true root cause.
- Author/review deviation reports, investigation protocols, and CAPA plans meeting 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, and stakeholders through closure; may lead Deviation Review Board meetings.
- Serve as a thought leader on the Analytical Compliance Excellence (ACE) team; support audit/inspection readiness.
- Drive improvement using deviation metric analysis; lead trend analysis across investigations and CAPA/change control to closure with escalation of at-risk items.
- Mentor junior investigators/staff on RCA, technical writing, and quality impact evaluation.
Basic Qualifications
- BS in Chemistry/Biochemistry/Engineering/Pharma Sciences/Biology (or related).
- BS + 6+ years or MS + 3+ years GMP manufacturing/quality/lab experience including deviation/OOS, RCA, and CAPA.
- Experience authoring regulated investigation protocols, technical reports, and CAPA plans.
- Must be authorized to work in the U.S. (Lilly does not sponsor visas).
Preferred Skills
- Working knowledge of ICH, FDA (21 CFR Parts 210/211), and cGMP/data integrity (ALCOA+).
- Experience with TrackWise/Veeva QMS and GMP documentation/informatics platforms.
- Strong technical writing and troubleshooting on GMP equipment/analytical instrumentation; QRM/risk and change control experience; experience with inspections/audits.
Benefits (as stated)
- Eligibility for 401(k), pension, vacation; medical/dental/vision; flexible benefits; life insurance; certain time-off/leave; well-being benefits; eligible for company bonus.
Other Information
- Location: Lilly Technology Center (initial) then Lilly Medicine Foundry, Lebanon, IN. Travel 0–10%. First shift; occasional off-shift/weekend/holiday coverage.