IDAP Engineer - MES Systems

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.

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 38,000 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 individuals who are determined to make life better for people around the world.

As a MES System Engineer supporting the Indianapolis Device Assembly & Packaging (IDAP) site, you will play a critical role in implementing and sustaining our next-generation Manufacturing Execution System (MES). This system is central to our digital transformation strategy, supporting paperless operations, enhancing compliance, and enabling efficient batch execution.

You will work closely with site Operations, Quality, Engineering, and IT teams to translate operational needs into executable MES solutions. This role is ideal for someone who is passionate about technology, systems thinking, and supporting frontline manufacturing teams.

You will be responsible for implementing, configuring, and supporting the MES solution at IDAP, ensuring that it meets the site’s operational, quality, and compliance needs. You will work closely with Operations, Engineering, Quality, and the broader Tech at Lilly team to ensure successful deployment and long-term support of MES capabilities

• Implement, configure, and support the MES platform for device assembly and packaging operations at IDAP.

• Partner with site teams to gather requirements, define digital workflows, and author/validate electronic batch records aligned with operational processes.

• Execute and support site-level testing and validation efforts (e.g., Installation Qualification, Performance Qualification) to ensure system readiness.

• Troubleshoot MES issues and collaborate with cross-functional teams to resolve system or process gaps.

• Support site readiness and go‑live efforts, including hyper‑care support and frontline troubleshooting.

• Ensure compliance with Computer System Validation (CSV) standards, including 21 CFR Part 11 and GAMP 5.

• Develop and maintain system documentation, SOPs, training materials, and support guides tailored to IDAP operations.

• Collaborate with global/site MES architects and platform teams to align on standards, design, and configuration best practices.

• Identify opportunities for continuous improvement, error‑proofing, and digital optimization at the site.

• Actively engage in site huddles, team discussions, and problem‑solving initiatives

• Experience supporting MES in a regulated manufacturing environment, ideally in device assembly or packaging operations.

• Working knowledge of cGMP and Computer System Validation (CSV) frameworks

• Ability to interpret process requirements and translate them into MES configurations or electronic batch records.

• Strong troubleshooting skills, with the ability to investigate system issues, identify root causes, and implement sustainable solutions.

• Comfortable working on the shop floor with operations, quality, and engineering teams to gather feedback and support adoption.

• Excellent collaboration and communication skills able to navigate cross‑functional environments and bridge technical and business teams.

• Ability to manage multiple priorities and adapt to changing project needs.

• Proactive mindset with a focus on continuous improvement and…