Informatics Engineer - Lilly Medicine Foundry
About The Position
At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us. Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in Lebanon, IN. 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.
Requirements
- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.
- 1+ year of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area.
- 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 and visas for this role, 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.
Nice To Haves
- 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 with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.
- Understanding of data integrity frameworks applicable to GMP lab environments.
- Familiarity with Agile or iterative delivery methodologies in a regulated setting.
- Demonstrated learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues through sound problem-solving.
- Ability to accurately translate business and scientific processes into IT requirements and solutions.
- Effective communicator across diverse forums and audiences, including technical peers, QA, and business customers.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.
Responsibilities
- 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.
- Drive and support system design, configuration, validation, and release - serving as an IT domain expert (SME) for analytical laboratory IT systems at the Foundry.
- 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.
- 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.
- 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.
Benefits
- company bonus (depending, in part, on company and individual performance)
- company-sponsored 401(k)
- pension
- vacation benefits
- medical benefits
- dental benefits
- vision benefits
- prescription drug benefits
- flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
- life insurance
- death benefits
- certain time off and leave of absence benefits
- well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
