Principal Scientist - Deviation & CAPA Leader

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 140,000 - 190,000; Full time

Job summary

Lilly Technology Center in Lebanon, IN is seeking a Principal Scientist - Deviation Management to lead deviation and OOS investigations, root cause analysis, CAPA development, and change control for Analytical GMP Laboratories (AGL).

You will author and review investigation reports and CAPA plans, mentor junior staff, collaborate cross-functionally with QA, Manufacturing, and Engineering, and drive CAPA effectiveness and audit readiness.

Qualifications

• Minimum BS in science or engineering with GMP experience.
• MS with 3+ years GMP experience preferred.
• Experience authoring investigation protocols, reports, and CAPA plans.

Responsibilities

• Lead deviation and OOS investigations using structured RCA methods.
• Author and review deviation reports, protocols, and CAPA plans.
• Draft change controls and assess impact on validated processes and systems.
• Mentor junior investigators and collaborate with QA/SMEs to closure.
• Support audit readiness by documenting deviation rationale and CAPA effectiveness.

Skills

Root cause analysis

Technical writing

Troubleshooting

Leadership

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Master's degree in relevant field

Tools

TrackWise

Veeva QMS

Lab informatics systems

Job description

Lilly Technology Center in Lebanon, IN is seeking a Principal Scientist - Deviation Management to lead deviation and OOS investigations, root cause analysis, CAPA development, and change control for Analytical GMP Laboratories (AGL).

You will author and review investigation reports and CAPA plans, mentor junior staff, collaborate cross-functionally with QA, Manufacturing, and Engineering, and drive CAPA effectiveness and audit readiness.