IDAP MES System Engineer Tech at Lilly

Eli Lilly and Company • Us, IN

4d • Onsite

About The Position

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.

Requirements

• 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 system optimization.
• Familiarity with system integration concepts (e.g., MES to ERP or automation systems).
• Willingness to learn and grow technical skills as the MES platform and site capabilities evolve.
• Bachelor’s degree in IT, computer science, computer engineering or related field.
• 2+ years experience with MES system design, implementation, and validation.
• 3+ years of experience in regulated pharmaceutical or medical device manufacturing environments.
• Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization and visas for this role.

Nice To Haves

• 2+ years MES experience, and/or at least 1 year in PharmaSuite deployments.
• Familiarity with MES platforms such as PMX, PharmaSuite, Werum PAS-X, Emerson Syncade, DeltaV or similar is strongly preferred.
• Experience with Microsoft Office Suite (Excel, Word, PowerPoint).
• Strong communication skills (written and verbal) with the ability to communicate at all levels of the organization.
• Proven experience in stakeholder management and cross-functional coordination.
• Understanding of GMP regulations and Computer System Validation (CSV) principles (e.g., GAMP 5, 21 CFR Part 11, Annex 11).
• Experience authoring and validating Master Batch Records (MBRs) in a regulated environment.
• Strong documentation skills and attention to detail, with experience in generating validation deliverables and training materials.
• Ability to work cross-functionally and communicate effectively with technical and non-technical stakeholders.

Responsibilities

• 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 hypercare 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.

Benefits

• company bonus (depending, in part, on company and individual performance)
• company-sponsored 401(k)
• pension
• vacation benefits
• medical, dental, vision and prescription drug benefits
• flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts)
• life insurance and death benefits
• certain time off and leave of absence benefits
• well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level