MES Engineer - Medicine Foundry

Position: MES Engineer - Lilly Medicine Foundry
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

** Lilly's Purpose*
* At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism.

We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.

** 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. This role sits at the intersection of systems configuration, GxP compliance, and operational collaboration requiring someone who can drive alignment across engineering, operations, and quality stakeholders.

Key responsibilities include:

+ Serving as the MES area lead for a manufacturing modality (e.g., small molecules, peptides, biologics), owning end-to-end configuration and delivery.

+ Configuring, building, and testing MES workflows, electronic batch records (eBRs), and digital work instructions aligned to manufacturing process requirements.

+ Partnering with process engineers, operations, and to translate manufacturing procedures into MES-executable digital workflows.

+ Supporting IQ/OQ/PQ validation activities, authoring and reviewing validation lifecycle documents, and ensuring compliance with 21 CFR Part 11, GAMP 5, and Lilly CSV/CSA standards.

+ Coordinating with the MES vendor on area-specific requirements, issue resolution, and deliverable review.

+ Facilitating user acceptance testing (UAT) and supporting end-user training and go-live readiness activities for your area.

+ Communicating status, risks, and issues to the MES Project Manager and broader leadership in a clear and timely manner.

** How You Will Succeed:*
* + 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, escalate risks proactively, and work with the broader implementation team and 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.

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