MES Engineer - Lilly Medicine Foundry
Eli Lilly and Company
19 days ago
On-site
Indianapolis, IN
Operations
What You’ll Be Doing
As an MES Engineer at the Lilly Medicine Foundry, you will serve as both a hands-on technical practitioner and the functional lead for a manufacturing modality area for a SaaS-based MES implementation, driving alignment across engineering, operations, and quality stakeholders.
Key Responsibilities
- Serve as MES area lead for a manufacturing modality (small molecules, peptides, biologics), owning end-to-end configuration and delivery.
- Configure, build, and test MES workflows, electronic batch records (eBRs), and digital work instructions.
- Partner to translate manufacturing procedures into MES-executable digital workflows.
- Support IQ/OQ/PQ validation; author/review validation lifecycle documents; ensure compliance with 21 CFR Part 11, GAMP 5, and Lilly CSV/CSA standards.
- Coordinate with MES vendor; resolve issues; review deliverables.
- Facilitate UAT; support end-user training and go-live readiness.
- Communicate status, risks, and issues to the MES Project Manager and leadership.
How You Will Succeed (Skills/Competencies)
- Hands-on MES implementation/deployment in a pharmaceutical GMP environment (recipe management, eBR authoring, electronic workflow design).
- Lead modality through requirements, configuration, testing, validation, and go-live.
- Troubleshoot MES configuration; support root cause analysis.
- Ensure data integrity and cybersecurity adherence.
- Translate MES capabilities/constraints for operators and quality; champion adoption/change management.
What You Should Bring (Qualifications)
- Hands-on experience configuring and implementing a commercial MES (Apprentice Tempo, Rockwell Pharma Suite, Emerson Syncade, Siemens Opcenter, or equivalent) in GMP.
- Experience translating SOPs/batch records into MES-executable eBRs/workflows/recipes.
- Solid GMP understanding; 21 CFR Part 11 electronic records.
- CSV experience (URS/Functional Specs/IQ-OQ-PQ) under GAMP 5 or equivalent.
- Ability to lead/co-lead an MES/IT workstream; coordinate tasks and reporting.
- Working knowledge of pharma manufacturing operations relevant to at least one modality.
- Strong analytical problem-solving; comfort in greenfield environments.
- MES integration knowledge (automation systems, ERP, LIMS, data infrastructure).
Your Basic Qualifications
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or related.
- 5+ years with pharmaceutical manufacturing systems or MES platforms.
- 2+ years supporting/leading CSV in a GMP-regulated environment.
- Experience working within or alongside pharmaceutical manufacturing operations.
Location
- Initial: Indianapolis, Indiana. Permanent: Lilly Medicine Foundry, Lebanon, Indiana.
As an MES Engineer at the Lilly Medicine Foundry, you will serve as both a hands-on technical practitioner and the functional lead for a manufacturing modality area for a SaaS-based MES implementation, driving alignment across engineering, operations, and quality stakeholders.
Key Responsibilities
- Serve as MES area lead for a manufacturing modality (small molecules, peptides, biologics), owning end-to-end configuration and delivery.
- Configure, build, and test MES workflows, electronic batch records (eBRs), and digital work instructions.
- Partner to translate manufacturing procedures into MES-executable digital workflows.
- Support IQ/OQ/PQ validation; author/review validation lifecycle documents; ensure compliance with 21 CFR Part 11, GAMP 5, and Lilly CSV/CSA standards.
- Coordinate with MES vendor; resolve issues; review deliverables.
- Facilitate UAT; support end-user training and go-live readiness.
- Communicate status, risks, and issues to the MES Project Manager and leadership.
How You Will Succeed (Skills/Competencies)
- Hands-on MES implementation/deployment in a pharmaceutical GMP environment (recipe management, eBR authoring, electronic workflow design).
- Lead modality through requirements, configuration, testing, validation, and go-live.
- Troubleshoot MES configuration; support root cause analysis.
- Ensure data integrity and cybersecurity adherence.
- Translate MES capabilities/constraints for operators and quality; champion adoption/change management.
What You Should Bring (Qualifications)
- Hands-on experience configuring and implementing a commercial MES (Apprentice Tempo, Rockwell Pharma Suite, Emerson Syncade, Siemens Opcenter, or equivalent) in GMP.
- Experience translating SOPs/batch records into MES-executable eBRs/workflows/recipes.
- Solid GMP understanding; 21 CFR Part 11 electronic records.
- CSV experience (URS/Functional Specs/IQ-OQ-PQ) under GAMP 5 or equivalent.
- Ability to lead/co-lead an MES/IT workstream; coordinate tasks and reporting.
- Working knowledge of pharma manufacturing operations relevant to at least one modality.
- Strong analytical problem-solving; comfort in greenfield environments.
- MES integration knowledge (automation systems, ERP, LIMS, data infrastructure).
Your Basic Qualifications
- Bachelor’s degree in Software Engineering, Computer Science, Computer Engineering, or related.
- 5+ years with pharmaceutical manufacturing systems or MES platforms.
- 2+ years supporting/leading CSV in a GMP-regulated environment.
- Experience working within or alongside pharmaceutical manufacturing operations.
Location
- Initial: Indianapolis, Indiana. Permanent: Lilly Medicine Foundry, Lebanon, Indiana.