Lead Deviation & CAPA Investigator

BioSpace; Lebanon (IN); On-site; USD 65,000 - 169,000; Full time

Benefits offered by this job

Company bonus

401(k) plan

Vacation benefits

Medical, dental, vision benefits

Job summary

Lilly is seeking a Principal Scientist in Deviation Management to lead deviation and OOS investigations, detailed root-cause analysis, CAPA development, and change control within the Analytical GMP environment at the Lilly Medicine Foundry in Lebanon, Indiana.

Reporting to the Senior Advisor, you will mentor junior investigators, draft technically sound reports, and be a quality champion on the ACE team, partnering with Manufacturing, QA, and Engineering to ensure right‑first‑time regulatory

Qualifications

• BS in Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, Biology, or a related scientific/technical discipline.
• BS with 6+ years or MS with 3+ years of progressive GMP manufacturing, quality, or laboratory experience, including direct experience with deviation and OOS investigations, root cause analysis, and CAPA.
• Demonstrated experience authoring investigation protocols, technical reports, and CAPA plans in a regulated environment.
• Authorized to work in the United States on a full‑time basis.

Responsibilities

• Lead deviation and OOS investigations (Minor, Major, Critical), applying structured root cause analysis methods (5-Why, fishbone, etc.) to determine true root cause.
• Author and review deviation reports, investigation protocols, and CAPA plans with defensible rationale meeting data integrity standards.
• Draft CAPA plans linked to verified root causes and author change control records assessing impact to validated processes, equipment, and systems.
• Perform hands-on troubleshooting and confirmatory testing to distinguish true deviations from anomalies; mentor stakeholders from assignment through closure.

Skills

Root cause analysis

Technical writing

CAPA planning

Leadership

GMP compliance

QA collaboration

Education

BS in Chemistry/related field

MS in related field

Tools

TrackWise

Veeva QMS

Lab informatics

Job description

Lilly is seeking a Principal Scientist in Deviation Management to lead deviation and OOS investigations, detailed root-cause analysis, CAPA development, and change control within the Analytical GMP environment at the Lilly Medicine Foundry in Lebanon, Indiana.

Reporting to the Senior Advisor, you will mentor junior investigators, draft technically sound reports, and be a quality champion on the ACE team, partnering with Manufacturing, QA, and Engineering to ensure right‑first‑time regulatory