Principal Informatics Engineer - Medicine Foundry

Position: Principal Informatics Engineer - Lilly Medicine Foundry
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. 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.

** Location & Work Flexibility*
* This role will initially be located out of Indianapolis, IN. Once constructed the permanent location will be based at our new Lilly Medicine Foundry in nearby Lebanon, IN. We offer a flexible hybrid work model, with  
** three days onsite and two days working remotely each week** , supporting both collaboration and work‑life balance.

** 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.

+

Experience with Computer System Validation (CSV) methodology.

** Additional Skills / Preferences:*
* + Strong working knowledge of analytical laboratory IT systems including:

+ LIMS:
Lab Vantage, Lab Ware

+ 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…