IDAP MES System Engineer Tech at Lilly
Eli Lilly and Company
August 06, 2026
On-site
Indianapolis, IN
Operations
Responsibilities:
- Implement, configure, and support the MES solution at Lilly’s Indianapolis Device Assembly & Packaging (IDAP) site.
- Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.
- Execute and support site-level testing and validation (e.g., IQ/PQ) to ensure system readiness.
- Troubleshoot MES issues and collaborate with cross-functional teams to resolve system/process gaps.
- Support site readiness and go-live (including hypercare and frontline troubleshooting).
- Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.
- Develop/maintain system documentation, SOPs, training materials, and support guides for IDAP.
- Collaborate with global/site MES architects and platform teams on standards, design, and configuration best practices.
- Drive continuous improvement, error-proofing, and digital optimization; participate in site huddles.
Required Qualifications:
- Bachelor’s degree in IT, computer science, computer engineering, or related field.
- 2+ years MES system design, implementation, and validation.
- 3+ years in regulated pharmaceutical or medical device manufacturing.
Preferred Qualifications / Skills:
- Experience supporting MES in regulated manufacturing (device assembly/packaging preferred).
- Working knowledge of cGMP and CSV.
- Ability to translate process requirements into MES configurations/electronic batch records.
- Strong troubleshooting; shop-floor collaboration; cross-functional communication.
- Familiarity with MES integrations (e.g., to ERP/automation).
- Familiarity with MES platforms (PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV) and Microsoft Office.
- Understanding GMP/CSV principles; experience authoring/validating Master Batch Records.
Location & Scheduling:
- Onsite at Lilly Tech Center South (IDAP); occasional travel 5–10%; flexibility for off-hours support during implementations.
Application Instructions:
- Complete the workplace accommodation request form if you need help submitting your resume.
- Implement, configure, and support the MES solution at Lilly’s Indianapolis Device Assembly & Packaging (IDAP) site.
- Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.
- Execute and support site-level testing and validation (e.g., IQ/PQ) to ensure system readiness.
- Troubleshoot MES issues and collaborate with cross-functional teams to resolve system/process gaps.
- Support site readiness and go-live (including hypercare and frontline troubleshooting).
- Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.
- Develop/maintain system documentation, SOPs, training materials, and support guides for IDAP.
- Collaborate with global/site MES architects and platform teams on standards, design, and configuration best practices.
- Drive continuous improvement, error-proofing, and digital optimization; participate in site huddles.
Required Qualifications:
- Bachelor’s degree in IT, computer science, computer engineering, or related field.
- 2+ years MES system design, implementation, and validation.
- 3+ years in regulated pharmaceutical or medical device manufacturing.
Preferred Qualifications / Skills:
- Experience supporting MES in regulated manufacturing (device assembly/packaging preferred).
- Working knowledge of cGMP and CSV.
- Ability to translate process requirements into MES configurations/electronic batch records.
- Strong troubleshooting; shop-floor collaboration; cross-functional communication.
- Familiarity with MES integrations (e.g., to ERP/automation).
- Familiarity with MES platforms (PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV) and Microsoft Office.
- Understanding GMP/CSV principles; experience authoring/validating Master Batch Records.
Location & Scheduling:
- Onsite at Lilly Tech Center South (IDAP); occasional travel 5–10%; flexibility for off-hours support during implementations.
Application Instructions:
- Complete the workplace accommodation request form if you need help submitting your resume.