CSV Engineer - Automation Engineering

Role: Automation Engineer at Lilly's new Medicines Foundry, supporting process automation systems validation, implementation, and compliance for GMP manufacturing. Responsibilities: lead CSV activities for systems including DCS, SCADA, BMS, MES, Historian; develop validation plans, execute validation protocols, conduct risk assessments, and maintain validation documentation; collaborate with vendors and cross-functional teams; support GMP operations and site startup from 2025 to 2028. Requirements: B.S. in Engineering; 2+ years in FDA-regulated environments; experience with computer system validation, regulatory standards (GAMP, 21 CFR Part 11, Data Integrity); strong problem-solving, communication, and organizational skills. Preferred: knowledge of GMP/GXP, automation in pharmaceutical manufacturing, experience with DeltaV, Rockwell, Syncade, LabVantage, OSI PI; experience in greenfield sites, system interconnectivity, and supporting quality compliance. HighValue: process automation, CSV, GMP, regulatory compliance, pharmaceutical manufacturing, greenfield site startup, validation of complex automation systems. WorkSetup: initial in Carmel, IN, permanent in Lebanon, Indiana; collaborative environment supporting project delivery, startup, and ongoing operations.