Principal Informatics Engineer

Eli Lilly and Company

Informatics Engineer partnering with IT teams to implement digital laboratory solutions for advanced drug development. Leading system design and validation at the Lilly Medicine Foundry in Lebanon, IN.

Posted 5/21/2026full-timeIndianapolis • 🇺🇸 United StatesLead💰 $126,000 - $224,400 per yearWebsite

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

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.
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

What you’ll need

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: 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.

Benefits

Comp & perks

Eligibility to participate in a company-sponsored 401(k)
Pension
Vacation benefits
Eligibility for medical, dental, vision and prescription drug benefits
Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
Life insurance and 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)

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Computer System Validation (CSV)Installation Qualification (IQ)Operational Qualification (OQ)Performance Qualification (PQ)API/middleware integrationLIMSLESELNCDSdata integrity

Soft Skills

problem-solvinglearning agilitycommunicationcollaborationleadership

Certifications

ITIL