MES Engineer - Lilly Medicine Foundry
Eli Lilly and Company
20 days ago
On-site
Lebanon, IN
Operations
What You’ll Be Doing
- Serve as MES Engineer for a SaaS-based MES implementation; functional lead for a manufacturing modality area.
Key Responsibilities
- Own end-to-end MES configuration and delivery for a modality (e.g., small molecules, peptides, biologics).
- Configure/build/test MES workflows, electronic batch records (eBRs), and digital work instructions.
- Translate manufacturing SOPs and procedures into MES-executable workflows with process engineering and operations.
- 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 the MES vendor; resolve issues and review deliverables.
- Facilitate UAT; support training and go-live readiness.
- Communicate status, risks, and issues; troubleshoot configuration defects and support root-cause analysis.
How You Will Succeed (Selected)
- Lead through MES lifecycle: requirements, configuration, testing, validation, go-live.
- Ensure data integrity and cybersecurity compliance; apply analytical/problem-solving in a greenfield environment.
What You Should Bring / Qualifications
- Hands-on MES platform experience in GMP pharma (Apprentice Tempo, Rockwell Pharma Suite, Emerson Syncade, Siemens Opcenter, or equivalent).
- Translate batch records/SOPs into MES eBRs, workflows, and recipes.
- GMP knowledge (batch execution, material tracking, equipment management; 21 CFR Part 11).
- CSV experience (URS/Functional specs/IQ-OQ-PQ) under GAMP 5 or equivalent.
- 5+ years MES/pharma manufacturing systems experience; 2+ years CSV in GMP-regulated environment.
- Bachelor’s degree in Software Engineering/CS/Computer Engineering or related field.
Benefits (as stated)
- Eligibility for company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Locations
- Initial: Indianapolis, Indiana. Permanent: Lilly Medicines Foundry, Lebanon, Indiana.
- Serve as MES Engineer for a SaaS-based MES implementation; functional lead for a manufacturing modality area.
Key Responsibilities
- Own end-to-end MES configuration and delivery for a modality (e.g., small molecules, peptides, biologics).
- Configure/build/test MES workflows, electronic batch records (eBRs), and digital work instructions.
- Translate manufacturing SOPs and procedures into MES-executable workflows with process engineering and operations.
- 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 the MES vendor; resolve issues and review deliverables.
- Facilitate UAT; support training and go-live readiness.
- Communicate status, risks, and issues; troubleshoot configuration defects and support root-cause analysis.
How You Will Succeed (Selected)
- Lead through MES lifecycle: requirements, configuration, testing, validation, go-live.
- Ensure data integrity and cybersecurity compliance; apply analytical/problem-solving in a greenfield environment.
What You Should Bring / Qualifications
- Hands-on MES platform experience in GMP pharma (Apprentice Tempo, Rockwell Pharma Suite, Emerson Syncade, Siemens Opcenter, or equivalent).
- Translate batch records/SOPs into MES eBRs, workflows, and recipes.
- GMP knowledge (batch execution, material tracking, equipment management; 21 CFR Part 11).
- CSV experience (URS/Functional specs/IQ-OQ-PQ) under GAMP 5 or equivalent.
- 5+ years MES/pharma manufacturing systems experience; 2+ years CSV in GMP-regulated environment.
- Bachelor’s degree in Software Engineering/CS/Computer Engineering or related field.
Benefits (as stated)
- Eligibility for company bonus; 401(k) and pension; vacation; medical/dental/vision/prescription; flexible benefits; life insurance; time off/leave; well-being benefits.
Locations
- Initial: Indianapolis, Indiana. Permanent: Lilly Medicines Foundry, Lebanon, Indiana.