Informatics Engineer: Lab IT Systems & Compliance

Initial Therapeutics, Inc.; Indianapolis (IN); On-site; USD 64,500 - 158,400; Full time

Benefits offered by this job

401(k)

Vacation benefits

Health benefits

Job summary

Lilly is seeking an Informatics Engineer to partner with lab SMEs and IT teams to implement and support digital laboratory solutions. You will focus on LIMS, LES, ELN, CDS, and EM platforms, driving design, validation, and data integrity in a GMP setting at the Indianapolis Foundry.

Responsibilities include configuring systems, validating IQ/OQ/PQ protocols, and ensuring regulatory readiness while collaborating across site and global IT teams. This role requires US work authorization.

Qualifications

• Bachelor's degree required in IT, Chemistry, Pharmacy, Science, Engineering, or related field.
• 1+ year of relevant IT/engineering experience, CSV, or quality control support.
• Experience with CSV methodology and regulatory expectations.

Responsibilities

• Lead system design and configuration for LIMS/LES/ELN/CDS platforms with lab SMEs.
• Develop IQ/OQ/PQ protocols in line with 21 CFR Part 11 and EU Annex 11.
• Maintain data integrity and audit readiness across lab systems.
• Coordinate instrument integration between labs and informatics platforms.
• Support site deployment and upgrades of analytical lab IT systems.

Skills

IT experience

CSV methodology

Regulatory awareness

GMP knowledge

Education

Bachelor's degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field

Tools

LIMS LabVantage

ELN Benchling

CDS Empower

LES L7

Instrument integration

Job description

Lilly is seeking an Informatics Engineer to partner with lab SMEs and IT teams to implement and support digital laboratory solutions. You will focus on LIMS, LES, ELN, CDS, and EM platforms, driving design, validation, and data integrity in a GMP setting at the Indianapolis Foundry.

Responsibilities include configuring systems, validating IQ/OQ/PQ protocols, and ensuring regulatory readiness while collaborating across site and global IT teams. This role requires US work authorization.