CSV Engineer - Automation Engineering

Role: Automation Engineer supporting process control validation and compliance at Lilly's new Medicines Foundry. Responsibilities: develop and execute validation plans for automation systems (DCS, SCADA, MES, Historian, BMS), perform risk assessments, ensure GxP and 21 CFR Part 11 compliance, manage change control, and collaborate with vendors and cross-functional teams. Requirements: B.S. in Engineering, 2+ years in FDA-regulated environments, experience with computer system validation and automation systems. HighValue: focus on automation validation, data integrity, and GMP operations within a new greenfield manufacturing site; involvement in startup and project delivery phases (expected 2025-2028); located initially in Carmel, IN, with permanent site at Lebanon, IN. WorkSetup: on-site at the Lilly Medicines Foundry.