MES Engineer - Lilly Medicine Foundry

About the role

The MES Engineer at the Lilly Medicine Foundry 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.

Responsibilities

• 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.
• Coeordinating 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.

Qualifications

• Hands-on experience configuring and deploying MES platforms in a pharmaceutical GMP environment, ideally including recipe management, eBR authoring, and electronic workflow design.
• 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 risks within your area of responsibility, propose mitigations, and escalate appropriately within the project governance structure.
• Experience leading or co-leading a functional workstream within a larger IT or MES implementation project, including coordination of tasks, issue tracking, and stakeholder reporting.
• Working knowledge of pharmaceutical manufacturing operations (e.g., batch manufacturing, material handling, in-process controls) relevant to at least one modality such as small molecules, biologics, peptides, oligonucleotides, or ADCs.
• Excellent communication and collaboration skills; ability to build effective working relationships across manufacturing, engineering, quality, and IT functions in a greenfield environment.
• Strong analytical and problem-solving mindset, with demonstrated ability to work through ambiguity and keep deliverables on track in a fast-paced greenfield program.
• Comfort working in a greenfield startup environment where processes, priorities, and vendor deliverables are evolving; ability to manage multiple concurrent tasks and adapt quickly.
• Strong working knowledge of MES integration concepts, including how MES platforms connect with automation systems, ERP, LIMS, and data infrastructure in a pharmaceutical manufacturing context.