Laboratory IT System Engineer - Lilly Medicine Foundry
Eli Lilly and Company
9 hours ago
On-site
Lebanon, IN
IT
What You’ll Be Doing
- Implement and support digital laboratory solutions for the Lilly Medicine Foundry, partnering with Process Translation, Analytical Laboratories, and site/group/global IT teams.
- Serve as an IT subject matter expert (SME) for analytical laboratory IT systems covering LIMS, LES, ELN, CDS, and Environmental Monitoring (EM).
- Drive and support system design, configuration, validation, and release.
How You’ll Succeed
System Implementation & Configuration
- Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS; translate business/scientific processes into validated technical solutions.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11.
- Manage data integrity requirements across lab systems; ensure audit readiness for regulatory inspections.
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms.
- Support site deployment and upgrades of analytical laboratory IT systems throughout startup and operational phases.
Validation & Compliance
- Produce/maintain Computer System Validation (CSV) documentation, SOPs, and validation plans aligned with applicable regulatory frameworks.
- Ensure systems remain in a validated state; manage lifecycle through releases, recapitalization, and retirement.
- Build/maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory; ensure solution requirements comply.
Stakeholder Collaboration & Readiness
- Collaborate with site and global IT teams to ensure operational readiness for laboratory system go-live.
- Organize and educate peers on system use and best practices as a key IT SME.
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.
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.
- Demonstrated experience with Computer System Validation (CSV) methodology.
Additional Skills / Preferences
- Strong working knowledge of analytical laboratory IT systems, including: LIMS (LabVantage, LabWare or equivalent); 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 in a GMP-regulated environment (pharmaceutical/biotech or equivalent).
- Ability to prepare and execute 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/iterative delivery methodologies in a regulated setting.
- Learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues.
- Ability to translate business and scientific processes into IT requirements/solutions.
- Effective communicator with technical peers, QA, and business stakeholders.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.
Benefits (explicitly listed)
- Company bonus (depending, in part, on company and individual performance).
- Comprehensive benefits for eligible employees: 401(k) (company-sponsored), pension, vacation, medical/dental/vision/prescription drug benefits, flexible benefits (e.g., healthcare and/or dependent day care FSAs), life insurance and death benefits, certain time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs and activities).
Other Information
- Initial location: Indianapolis, Indiana.
- Permanent location: Lilly Medicine Foundry, Lebanon, Indiana.
- Implement and support digital laboratory solutions for the Lilly Medicine Foundry, partnering with Process Translation, Analytical Laboratories, and site/group/global IT teams.
- Serve as an IT subject matter expert (SME) for analytical laboratory IT systems covering LIMS, LES, ELN, CDS, and Environmental Monitoring (EM).
- Drive and support system design, configuration, validation, and release.
How You’ll Succeed
System Implementation & Configuration
- Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS; translate business/scientific processes into validated technical solutions.
- Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11.
- Manage data integrity requirements across lab systems; ensure audit readiness for regulatory inspections.
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms.
- Support site deployment and upgrades of analytical laboratory IT systems throughout startup and operational phases.
Validation & Compliance
- Produce/maintain Computer System Validation (CSV) documentation, SOPs, and validation plans aligned with applicable regulatory frameworks.
- Ensure systems remain in a validated state; manage lifecycle through releases, recapitalization, and retirement.
- Build/maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory; ensure solution requirements comply.
Stakeholder Collaboration & Readiness
- Collaborate with site and global IT teams to ensure operational readiness for laboratory system go-live.
- Organize and educate peers on system use and best practices as a key IT SME.
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.
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.
- Demonstrated experience with Computer System Validation (CSV) methodology.
Additional Skills / Preferences
- Strong working knowledge of analytical laboratory IT systems, including: LIMS (LabVantage, LabWare or equivalent); 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 in a GMP-regulated environment (pharmaceutical/biotech or equivalent).
- Ability to prepare and execute 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/iterative delivery methodologies in a regulated setting.
- Learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues.
- Ability to translate business and scientific processes into IT requirements/solutions.
- Effective communicator with technical peers, QA, and business stakeholders.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.
Benefits (explicitly listed)
- Company bonus (depending, in part, on company and individual performance).
- Comprehensive benefits for eligible employees: 401(k) (company-sponsored), pension, vacation, medical/dental/vision/prescription drug benefits, flexible benefits (e.g., healthcare and/or dependent day care FSAs), life insurance and death benefits, certain time off and leave of absence benefits, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs and activities).
Other Information
- Initial location: Indianapolis, Indiana.
- Permanent location: Lilly Medicine Foundry, Lebanon, Indiana.