Principal Informatics Engineer - Lilly Medicine Foundry

About the role

Lilly is seeking an Informatics Engineer to join the Lilly Medicine Foundry team. The Foundry is a new center for advanced manufacturing and drug development, with a focus on optimizing manufacturing processes and increasing capacity for clinical trial medicines.

Responsibilities

• Partner with analytical lab SMEs to implement and support digital laboratory solutions that enable Foundry’s operational objectives.
• Drive and support system design, configuration, validation, and release for key lab systems such as LIMS, LES, ELN, CDS, and EM platforms.
• 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 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 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

• 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.
• Strong working knowledge of analytical laboratory IT systems including: LIMS, ELN, CDS, LES/MES.
• 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.
• Adequate communication skills to effectively translate business and scientific processes into IT requirements and solutions.

Qualifications

• Strong problem-solving skills.
• Ability to work independently and as part of a team.
• Excellent organizational and time management skills.
• Ability to manage multiple projects simultaneously.
• Strong attention to detail.
• Ability to work in a fast-paced, deadline-driven environment.