MES Engineer

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.

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 Engineer is part of the new API facility's MES team, supporting the design, development, delivery, and computer system validation of DeltaV MES solution. You will implement, configure, and support the MES solution to meet the site's operational, quality, and compliance needs, working closely with Operations, Tech Services, Engineering, Quality, and the broader Tech at Lilly team to ensure successful deployment and long-term support of MES capabilities.

• Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.
• Support MES startup activities, including configuration of MES recipes, workflows, electronic work instructions, and electronic batch records (EBRs).
• Configuration of electronic logbooks (Equipment Tracking) and Weigh & Dispense
• Configuration of MES interfaces with other manufacturing systems (ERP system, Historian, DCS, Manufacturing Equipment via Edge technology, etc)
• Implement and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to ensure system readiness.
• Generation of associated CSV (Computer System Validation) documentation
• Troubleshoot MES issues and collaborate with multi-functional teams to resolve system or process gaps.
• Support site readiness and go-live efforts, including hypercare support and frontline troubleshooting.
• Ensure compliance with Lilly Global Standard Operating Procedures (GSOPs) and Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.
• Develop and maintain system documentation, SOPs, training materials, and support guides
• Collaborate with global/site MES architects and platform teams to align on standards, design, and configuration best practices.

• Pharmaceutical Manufacturing Regulatory compliance knowledge and experience (cGMP)
• Experience with DeltaV MES (Previously known as Syncade) Recipe Authoring and validating Master Batch Records (MBRs) in a regulated environment.
• Strong analytical and problem-solving skills across applications, configurations, and integrations.
• Excellent communication skills, with the…