MES System Engineer for Regulated Pharma Ops

100 Eli Lilly and Company

Indianapolis (IN)

On-site

USD 65,000 - 158,000

Full time

14 days+

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Job summary

Lilly invites applications for a MES Specialist to implement, configure, and support the MES platform for device assembly and packaging at the IDAP site. You will partner with cross‑functional teams to define workflows, author/validate electronic batch records, and support testing and validation activities.

Applicants should have 2+ years in MES design/validation and 3+ years in pharma/med device manufacturing, with strong CSV and GMP knowledge.

Qualifications

Bachelor's degree in IT, computer science, computer engineering or related field.
2+ years experience with MES system design, implementation, and validation.
3+ years of experience in regulated pharmaceutical or medical device manufacturing environments.
Authorized to work in the United States on a full‑time basis.
Familiarity with GMP and CSV principles (GAMP 5, 21 CFR Part 11, Annex 11).

Responsibilities

Implement, configure, and support the MES platform for device assembly and packaging operations at IDAP.
Partner with site teams to gather requirements, define digital workflows, and author/validate e‑batch records.
Execute and support site‑level testing and validation (IQ/OQ/PQ) to ensure system readiness.
Troubleshoot MES issues and collaborate with cross‑functional teams to resolve gaps.
Support site readiness and go‑live efforts, including hyper‑care support.
Ensure CSV compliance and 21 CFR Part 11 adherence.
Develop and maintain system documentation, SOPs, and training materials.
Collaborate with MES architects and platform teams to align on standards.
Identify opportunities for continuous improvement and digital optimization at the site.
Engage in site huddles and problem‑solving initiatives.