MES Architect

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.  MES Architect Houston API Manufacturing Site — Generation Park, Houston, TX 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 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. Lilly is investing $6.5 billion to build a new state-of-the-art active pharmaceutical ingredient (API) manufacturing site at Generation Park in Houston, Texas. The new site will produce APIs for small-molecule medicines for cardiometabolic health and will be built with the latest high-tech equipment, highly integrated and automated manufacturing systems, and a focus on minimizing environmental impact. This is a once-in-a-lifetime opportunity to help build and start up a new site.

The MES Architect owns the technical architecture and provides hands-on leadership for Manufacturing Execution Systems (MES) at the new Houston API facility. You will define the site's MES architecture and standards, lead and mentor the technical team delivering it, and hold deep accountability for validation rigor across the system's lifecycle. You will bring both strong platform expertise and strong leadership skills — partnering with Operations, Engineering, Quality, and the broader Tech at Lilly team to stand up and sustain MES capabilities for a greenfield site. Your Primary Responsibilities Own the end-to-end MES architecture for the Houston site — recipes, workflows, electronic work instructions, and electronic batch records (EBRs) — aligned to ISA-95/88 standards and operational, quality, and compliance needs. Define technical standards, design patterns, and configuration best practices for the site's MES platform, partnering with global MES architects and platform teams. Lead requirements gathering, solution design, and technical decision-making across the full implementation lifecycle, from concept through deployment. Architect integrations between the MES platform and adjacent enterprise and shop-floor systems (e.g., ERP, SCADA/DCS such as Emerson DeltaV) to ensure seamless, reliable data flow. Execute and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to confirm system readiness. Own Computer System Validation (CSV) rigor across the full system lifecycle, including 21 CFR Part 11 and GAMP 5 requirements. Lead and mentor a team of MES engineers, providing technical direction and quality review of designs and deliverables. Serve as the site's MES System Custodian and primary technical point of contact, representing Houston's MES needs to global platform and architecture forums. Build strong working relationships with Operations, Quality, Engineering, and site leadership to align priorities, gain buy-in, and drive adoption of MES capabilities. Support MES startup, site readiness, and go-live activities, including hypercare support and frontline troubleshooting.   What You Should Bring Strong understanding of pharmaceutical manufacturing processes and cGMP regulatory requirements. Strong leadership skills, with experience guiding technical teams and driving