IDAP MES System Engineer Tech at Lilly

Role: MES System Engineer supporting the Indianapolis Device Assembly & Packaging (IDAP) site, focused on implementing and maintaining the Manufacturing Execution System (MES) to enable paperless, compliant manufacturing workflows. Responsibilities include configuring MES solutions, translating operational requirements into digital workflows, executing validation efforts (IQ/PQ), troubleshooting, supporting site go-live, and ensuring compliance with CSV standards (21 CFR Part 11, GAMP 5). Collaboration involves working with Operations, Quality, Engineering, and IT teams to optimize digital operations and support continuous improvement initiatives. Requirements: Bachelor’s in IT or related field; 2+ years MES experience in regulated pharma or medical device manufacturing; strong knowledge of cGMP, CSV, and MES platforms (e.g., PharmaSuite, Werum PAS-X, Emerson Syncade). Preferred skills include MES deployment in PharmaSuite, familiarity with MES integrations, and experience authoring validation documentation. The role is onsite at Lilly’s IDAP site, with occasional travel (5-10%) and flexibility for off-hours support during manufacturing or implementation windows.