GMP Laboratory Informatics Systems Engineer

Lilly

Lebanon (IN)

On-site

USD 65,000 - 158,000

Full time

11 days ago

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Benefits offered by this job

Company bonus

Job summary

Lilly in Indianapolis, IN, is seeking an Informatics Engineer to partner with Process Translation and Analytical Laboratories to implement digital lab solutions (LIMS, LES, ELN, CDS) at the Lilly Medicine Foundry in Lebanon, IN. You will translate scientific processes into validated IT solutions, lead IQ/OQ/PQ activities, and ensure data integrity in a GMP setting.

A BS in a technical field and 1+ year IT experience are required; LabVantage, LabWare, Benchling or Signals Notebook experience is

Qualifications

  • BS in IT, Chemistry, Pharmacy, Science, Engineering, or related field.
  • 1+ year of IT or engineering experience in regulated environments.
  • Experience with LIMS/ELN and instrument data integrations.

Responsibilities

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

Skills

IT experience
Regulatory compliance

Education

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

Tools

LabVantage
LabWare
Benchling
Signals Notebook

Job description

Lilly in Indianapolis, IN, is seeking an Informatics Engineer to partner with Process Translation and Analytical Laboratories to implement digital lab solutions (LIMS, LES, ELN, CDS) at the Lilly Medicine Foundry in Lebanon, IN. You will translate scientific processes into validated IT solutions, lead IQ/OQ/PQ activities, and ensure data integrity in a GMP setting.

A BS in a technical field and 1+ year IT experience are required; LabVantage, LabWare, Benchling or Signals Notebook experience is

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