Informatics Engineer: GMP Lab IT Systems & Data Integrity

Scorpion Therapeutics; Indianapolis (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

Lilly in Lebanon, IN is seeking an Informatics Engineer to support digital laboratory solutions and enable manufacturing and drug development processes.

You will lead design, configuration, validation, and deployment of lab IT systems and ensure data integrity and audit readiness, collaborating with global IT teams.

The role emphasizes regulatory compliance and collaboration with site leadership to advance clinical and commercial drug development.

Qualifications

• Bachelor's degree in IT, Chemistry, Pharmacy, Science, Engineering or related field.
• 1+ year in IT, computer system validation, or QC support.
• Experience with LIMS (LabVantage/LabWare) and ELN (Benchling/Signals Notebook).
• Familiarity with CSV, electronic records/eSignatures, and GMP-regulated environments.

Responsibilities

• Lead design, configuration, validation, and deployment of key lab IT systems (LIMS, LES, ELN, CDS, and EM platforms).
• Develop validation protocols aligned with 21 CFR Part 11 and EU Annex 11 and ensure data integrity and audit readiness.
• Support system upgrades, site deployment, and audits; collaborate with global IT teams and act as SME for analytical lab systems.
• Produce validation documentation and SOPs; support regulatory inspections and audits.

Skills

Analytical lab IT

Agile methodologies

Education

Bachelor's degree in IT/Science/Engineering

Tools

LIMS (LabVantage/LabWare)

ELN (Benchling/Signals Notebook)

Job description

Lilly in Lebanon, IN is seeking an Informatics Engineer to support digital laboratory solutions and enable manufacturing and drug development processes.

You will lead design, configuration, validation, and deployment of lab IT systems and ensure data integrity and audit readiness, collaborating with global IT teams.

The role emphasizes regulatory compliance and collaboration with site leadership to advance clinical and commercial drug development.