MES Engineer - Lilly Medicine Foundry

About the Role

As an MES Engineer at the Lilly Medicine Foundry, you will serve as a hands‑on technical practitioner and functional lead for a manufacturing modality area for a SaaS‑based MES implementation. This role sits at the intersection of systems configuration, GxP compliance, and operational collaboration, requiring alignment across engineering, operations, and quality stakeholders.

• Serve as the MES area lead for a manufacturing modality (e.g., 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 aligned to manufacturing process requirements.
• Partner with process engineers, operations, and quality to translate manufacturing procedures into MES‑executable digital workflows.
• Support IQ/OQ/PQ validation activities, author and review validation lifecycle documents, and ensure compliance with 21 CFR Part 11, GAMP 5, and Lilly CSV/CSA standards.
• Coordinate with the MES vendor on area‑specific requirements, issue resolution, and deliverable review.
• Facilitate user acceptance testing (UAT) and support end‑user training and go‑live readiness activities for your area.
• Communicate status, risks, and issues to the MES Project Manager and broader leadership in a clear and timely manner.

• Bring hands‑on experience configuring and deploying MES platforms in a pharmaceutical GMP environment, ideally including recipe management, e  authoring, and electronic workflow design.
• Lead modality area through all phases of the MES implementation lifecycle — from requirements gathering and configuration through testing, validation, and go‑live support.
• Serve as the primary MES technical contact for your area, translating requirements into functional MES workflows in collaboration with process engineering and operations.
• Anticipate configuration challenges within your modality scope, proactively escalate risks, and work with the broader implementation team to drive timely resolution.
• Build a working understanding of the Foundry manufacturing processes, unit operations, and quality expectations, applying that knowledge directly to MES configuration and validation decisions.
• Ensure all MES configurations and data flows adhere to data integrity principles, 21 CFR Part 11, and Lilly cybersecurity requirements.
• Apply strong analytical and problem‑solving skills to troubleshoot MES configuration issues, triage defects during testing, and support root cause analysis during and after go‑live.
• Communicate effectively with both technical colleagues and non‑technical manufacturing stakeholders; translate MES capabilities and constraints into terms operators and quality staff can act on.
• Champion end‑user adoption, supporting training, change management, and on‑the‑floor go‑live assistance in coordination with the broader MES project team.
• Review and approve documentation related to areas of responsibility (Validation Lifecycle documents, executed IQPQ protocols, etc.) as appropriate.
• Stay active and current in business technology trends, direction and innovation related to business process and technology areas of focus by participating in external forums, conferences, and other venues as necessary.

• Hands‑on experience configuring and implementing a commercial MES platform (Apprentice Tempo, Rockwell Pharma Suite, Emerson Syncade, Siemens Opcenter, or equivalent) in a GMP pharmaceutical manufacturing environment.
• Demonstrated ability to translate manufacturing SOPs, batch records, and process requirements into MES‑executable electronic batch records (eBRs), digital work instructions, and recipes.
• Solid understanding of GMP manufacturing concepts, including batch execution, material tracking, equipment management, and electronic records requirements under 21 CFR Part 11.
• Experience participating in or leading Computer System Validation (CSV) activities, including authoring or reviewing User Requirements Specifications (URS), Functional Specifications, and IQ/OQ/PQ protocols under GAMP 5 or equivalent frameworks.
• Ability to identify and communicate technical…