Job Description
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. What You’ll Be Doing As an Informatics Engineer, you will partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry’s operational objectives. Your scope includes key lab systems such as Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms. You will be driving and supporting system design, configuration, validation, and release - serving as an IT domain expert (SME) for analytical laboratory IT systems at the Foundry. How You’ll Succeed System Implementation & Configuration Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions. Develop and implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11. Lead data integrity requirements across lab systems and ensure audit readiness for regulatory inspections. Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms. Support site deployment and upgrade of analytical laboratory IT systems throughout the facility’s startup and operational phases. Validation & Compliance Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks. Ensure systems remain in a validated state and lead their lifecycle through releases, recapitalization, and retirement. Build and maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory, ensuring solution requirements comply. Collaboration & Readiness Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry’s release objectives. Act as a key IT SME for analytical laboratory IT systems, organizing and educating peers on system use and best practices. Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation. Your Basic Qualifications Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field. 3+ years of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area. Demonstrated experience with Computer System Validation (CSV) methodology. Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, now or in the future, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1. Additional Skills / Preferences Strong working knowledge of analytical laboratory IT systems including: LIMS: LabVantage, LabWare ELN: Benchling, Signals Notebook, or equivalent CDS: Empower, or equivalent LES/MES: L7, MODA, or equivalent Solid knowledge of CSV process and electronic records/electronic signatures (ERES) requirements. Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent). Demonstrated ability to prepare and implement IQ/OQ/PQ protocols and associated documentation. Experience