Informatics Engineer - Lilly Medicine Foundry

About the role

Lilly is seeking an Informatics Engineer to join the Lilly Medicine Foundry team. The Foundry combines research and manufacturing in a single location, aiming to optimize processes, reduce costs, and enhance environmental sustainability. The role involves implementing and supporting digital laboratory solutions that align with the Foundry's operational goals.

Responsibilities

• Partner with Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions.
• Drive and support system design, configuration, validation, and release for key lab systems such as LIMS, LES, ELN, CDS, and EM platforms.
• Translate business and scientific processes into validated technical solutions.
• Develop and implement IQ, OQ, and PQ protocols in compliance with 21 CFR Part 11 and EU Annex 11.
• Ensure 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, SOPs, and validation plans in alignment with applicable regulatory frameworks.
• Lead the lifecycle of systems 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.

Requirements

The ideal candidate will have a Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or a related field, with 1+ years of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area. Qualified applicants must be authorized to work in the United States on a full-time basis.

Qualifications

• Strong working knowledge of analytical laboratory IT systems including LIMS, ELN, CDS, LES/MES, and EM platforms.
• Experience with CSV methodology and electronic records/electronic signatures (ERES) requirements.
• Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent).
• 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.
• Familiarity with data integrity frameworks applicable to GMP lab environments.
• Understanding of 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.
• 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.

Benefits

Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; medical, dental, vision, and prescription drug benefits; flexible benefits; life insurance and death benefits; time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

Pay

The anticipated wage for this position is $64,500 - $158,400.

Schedule

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.