Laboratory IT System Engineer - Lilly Medicine Foundry
Eli Lilly and Company
5 hours ago
On-site
Indianapolis, IN
IT
Laboratory IT Systems Engineer – Lilly Medicine Foundry
Responsibilities
- Partner with Process Translation and Analytical Laboratories and site/group/global IT teams to implement and support digital laboratory solutions.
- Serve as IT subject matter expert (SME) for analytical laboratory IT systems (LIMS, LES, ELN, CDS, EM).
- Drive and support system design, configuration, validation, and release.
- Lead system design/configuration sessions with analytical lab SMEs; translate business and scientific processes into validated technical solutions.
- Develop and execute IQ/OQ/PQ protocols in compliance with 21 CFR Part 11 and EU Annex 11.
- Manage data integrity requirements; ensure audit readiness for regulatory inspections.
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES.
- Support site deployment and upgrades during startup and operational phases.
- Produce/maintain Computer System Validation (CSV) documentation, SOPs, and validation plans.
- Maintain systems in a validated state and manage lifecycle through releases, recapitalization, and retirement.
- Collaborate with IT teams to ensure operational readiness for go-live objectives.
- Act as key SME for system use/best practices; organize and educate peers.
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.
Basic Qualifications
- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.
- 3+ years of relevant experience in IT, engineering, computer system validation, quality control support, or related area.
- Demonstrated experience with Computer System Validation (CSV) methodology.
Additional Skills / Preferences
- Working knowledge of analytical lab IT systems: 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.
- Ability to prepare/execute IQ/OQ/PQ protocols and documentation.
- Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.
- Understanding of GMP lab data integrity frameworks; familiarity with Agile/iterative delivery in regulated settings.
- Ability to analyze and resolve complex issues; translate business/scientific processes into IT requirements.
- Effective communicator with technical peers, QA, and business stakeholders.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.
Benefits (if explicitly stated)
- Eligible for company bonus (depending on company/individual performance).
- Comprehensive benefit program, including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Other Information (from listing)
- Initial location: Indianapolis, Indiana; permanent location: Lilly Medicines Foundry, Lebanon, Indiana.
Responsibilities
- Partner with Process Translation and Analytical Laboratories and site/group/global IT teams to implement and support digital laboratory solutions.
- Serve as IT subject matter expert (SME) for analytical laboratory IT systems (LIMS, LES, ELN, CDS, EM).
- Drive and support system design, configuration, validation, and release.
- Lead system design/configuration sessions with analytical lab SMEs; translate business and scientific processes into validated technical solutions.
- Develop and execute IQ/OQ/PQ protocols in compliance with 21 CFR Part 11 and EU Annex 11.
- Manage data integrity requirements; ensure audit readiness for regulatory inspections.
- Coordinate instrument integration and data flows between lab equipment and LIMS/LES.
- Support site deployment and upgrades during startup and operational phases.
- Produce/maintain Computer System Validation (CSV) documentation, SOPs, and validation plans.
- Maintain systems in a validated state and manage lifecycle through releases, recapitalization, and retirement.
- Collaborate with IT teams to ensure operational readiness for go-live objectives.
- Act as key SME for system use/best practices; organize and educate peers.
- Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.
Basic Qualifications
- Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.
- 3+ years of relevant experience in IT, engineering, computer system validation, quality control support, or related area.
- Demonstrated experience with Computer System Validation (CSV) methodology.
Additional Skills / Preferences
- Working knowledge of analytical lab IT systems: 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.
- Ability to prepare/execute IQ/OQ/PQ protocols and documentation.
- Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.
- Understanding of GMP lab data integrity frameworks; familiarity with Agile/iterative delivery in regulated settings.
- Ability to analyze and resolve complex issues; translate business/scientific processes into IT requirements.
- Effective communicator with technical peers, QA, and business stakeholders.
- Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.
Benefits (if explicitly stated)
- Eligible for company bonus (depending on company/individual performance).
- Comprehensive benefit program, including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave, and well-being benefits (e.g., employee assistance program, fitness benefits, employee clubs/activities).
Other Information (from listing)
- Initial location: Indianapolis, Indiana; permanent location: Lilly Medicines Foundry, Lebanon, Indiana.