Lab Systems Engineer
Eli Lilly and Company
August 18, 2026
On-site
Lebanon, IN
IT
Responsibilities:
- Ensure laboratory systems (MODA, LabVantage, NuGenesis, Empower, WInKQCL, etc.) and computerized analytical instruments are deployed with right-sized validation documentation at LP1.
- Monitor, execute, and maintain Laboratory IT systems/instruments with focus on continuous improvement and data integrity.
- Lead/support lab validation of equipment and software systems (IQ/OQ/PQ) and computerized system validation across GAMP 5 categories.
- Maintain the validated state via periodic review cycles; confirm ongoing compliance and fitness for intended use.
- Partner with DI SMEs on audit trail management, workstation security, and connecting stand-alone equipment.
- Support deployment/upgrades of lab IT systems (MODA, Empower, NuGenesis, LabVantage) with required CSV.
- Support audits/inspections; perform change control, investigations, root cause analysis, and activity planning.
- Coordinate Data Integrity/CSV technical evaluations of new/existing lab systems and instruments.
- Provide CSV consulting to articulate CSV needs to third-party service providers.
- Lead/participate in DI/CSV deviations and CAPAs for LP1 labs scope.
- Perform System Administration for E3B.
- Lead team of contract resources managing/supporting lab instruments.
Qualifications (Basic):
- BS in IT, Engineering, Computer Science, or related field.
- 5+ years in CSV in a regulated (GMP) environment; strong understanding of IT quality processes for manufacturing.
- Must be authorized to work in the U.S. (Lilly does not sponsor visas/work authorization).
Skills/What You Should Bring:
- Strong Data Integrity; experience implementing DI enhancements in systems and instruments.
- CSV proficiency; risk-based validation.
- Knowledge of CSV, Computer System Validation, GAMP, and GMP; cGMP.
- Communication, analytical/problem-solving, prioritization; agile/framework lifecycle experience.
- Cybersecurity awareness; ability to mentor.
- Experience deploying new systems; greenfield/stand-up experience.
- Previous Agile experience; exposure to global/international teams/projects.
Other Information:
- Monday–Friday, on-site (Lebanon, IN). Flexible support; occasional off-hours may be required.
- Ability to travel as needed.
- Ensure laboratory systems (MODA, LabVantage, NuGenesis, Empower, WInKQCL, etc.) and computerized analytical instruments are deployed with right-sized validation documentation at LP1.
- Monitor, execute, and maintain Laboratory IT systems/instruments with focus on continuous improvement and data integrity.
- Lead/support lab validation of equipment and software systems (IQ/OQ/PQ) and computerized system validation across GAMP 5 categories.
- Maintain the validated state via periodic review cycles; confirm ongoing compliance and fitness for intended use.
- Partner with DI SMEs on audit trail management, workstation security, and connecting stand-alone equipment.
- Support deployment/upgrades of lab IT systems (MODA, Empower, NuGenesis, LabVantage) with required CSV.
- Support audits/inspections; perform change control, investigations, root cause analysis, and activity planning.
- Coordinate Data Integrity/CSV technical evaluations of new/existing lab systems and instruments.
- Provide CSV consulting to articulate CSV needs to third-party service providers.
- Lead/participate in DI/CSV deviations and CAPAs for LP1 labs scope.
- Perform System Administration for E3B.
- Lead team of contract resources managing/supporting lab instruments.
Qualifications (Basic):
- BS in IT, Engineering, Computer Science, or related field.
- 5+ years in CSV in a regulated (GMP) environment; strong understanding of IT quality processes for manufacturing.
- Must be authorized to work in the U.S. (Lilly does not sponsor visas/work authorization).
Skills/What You Should Bring:
- Strong Data Integrity; experience implementing DI enhancements in systems and instruments.
- CSV proficiency; risk-based validation.
- Knowledge of CSV, Computer System Validation, GAMP, and GMP; cGMP.
- Communication, analytical/problem-solving, prioritization; agile/framework lifecycle experience.
- Cybersecurity awareness; ability to mentor.
- Experience deploying new systems; greenfield/stand-up experience.
- Previous Agile experience; exposure to global/international teams/projects.
Other Information:
- Monday–Friday, on-site (Lebanon, IN). Flexible support; occasional off-hours may be required.
- Ability to travel as needed.