Role: Informatics Engineer supporting digital laboratory solutions at Lilly's new Medicine Foundry in Lebanon, IN, focusing on enabling manufacturing and drug development processes.
Responsibilities
- lead design, configuration, validation, and deployment of key lab IT systems including LIMS, LES, ELN, CDS, and EM platforms; develop validation protocols aligned with 21 CFR Part 11 and EU Annex 11; ensure data integrity and audit readiness; support system upgrades and site deployment; collaborate with global IT teams and act as SME for analytical lab systems; produce validation documentation and SOPs; support regulatory inspections and audits.
Requirements
- Bachelor's in IT, Chemistry, Pharmacy, Science, Engineering, or related; 1+ year in IT, computer system validation, or QC support; experience with LIMS (LabVantage, LabWare), ELN (Benchling, Signals Notebook), and familiarity with CSV, electronic records/eSignatures, and GMP-regulated environments. Preferred: strong knowledge of analytical lab IT systems, API/middleware integration, data integrity frameworks, and experience with Agile methodologies. High-value: focus on GMP lab IT systems in biopharma manufacturing, supporting clinical and commercial drug development. Collaboration with site and global teams, reporting to site or IT leadership.
Location
Location: on-site in Lebanon, IN; travel requirements not specified.