MES Systems Engineer

About the role

The Tech@Lilly Manufacturing and Quality (MQ) team at the Indianapolis Parenteral Manufacturing (IPM) site is actively seeking a MES Systems Engineer to support digital transformation efforts. This role plays a crucial part in ensuring the safe and efficient manufacturing of life-saving medicines.

Responsibilities

• Support and evolve manufacturing execution systems (MES) at IPM site
• Work closely with cross-functional partners to understand manufacturing processes and translate them into system requirements, electronic Master Batch Records (MBRs), and MES solutions
• Design, configure, and support MES and digital execution solutions that enable safe, efficient pharmaceutical manufacturing
• Provide hands-on technical support for manufacturing systems, including MES, automation, and supporting IT infrastructure
• Troubleshoot equipment, software, and network-related issues to minimize downtime and support reliable production
• Partner with Engineering, Operations, Quality, and IT to investigate issues, identify root causes, and implement sustainable solutions
• Contribute to the design of integrated, scalable, and user-friendly MES solutions, ensuring seamless integration across manufacturing and digital platforms
• Apply technical expertise to translate business and manufacturing needs into practical system designs and configurations
• Incorporate security, data integrity, and compliance considerations into system designs to protect company data and meet regulatory expectations
• Communicate technical concepts clearly to both technical and non-technical stakeholders, supporting informed decision-making
• Build a strong understanding of IPM manufacturing processes and use that knowledge to support and improve operational workflows
• Support adoption of new and existing digital solutions by working with business SMEs and aligning with site and IT strategies
• Collaborate with global and local technical experts to help shape solution direction and balance usability, performance, and maintainability
• Participate in the review and approval of validation and lifecycle documentation (e.g., SOPs, protocols, and system records) to support compliant system delivery

Requirements

• Experience supporting Manufacturing Execution Systems (MES), such as PMX and/or PharmaSuite, with the ability to translate manufacturing needs into system requirements, configurations, and electronic batch record (eMBR) updates
• Exposure to or interest in supporting MES platform transitions, including learning and contributing to PMX → PharmaSuite migration activities in a phased manufacturing environment
• Experience in computer system validation (CSV) activities, including s execution and documentation, with an understanding of data integrity expectations in a regulated environment
• Ability to help gather and document non-functional requirements (performance, security, usability, data integrity, reliability) and work collaboratively with other MES engineers or architects to implement solutions that meet those needs
• Hands-on troubleshooting skills for MES-related issues, including application behavior, system interfaces, and connectivity, with a collaborative approach to identifying root causes and reducing production downtime
• Strong collaboration skills and experience working with cross-functional teams such as Operations, Engineering, Quality, and IT to support adoption and sustained use of digital manufacturing solutions
• Awareness of secure and compliant system use, including following access, security, and data protection practices in regulated manufacturing systems
• Exposure to reporting, dashboards, or manufacturing data flows, with the ability to support data continuity as systems modernize
• Experience supporting project execution through task tracking, status updates, and coordination within a defined workstream or project team
• Curiosity and a growth mindset, with an interest in learning new technologies and manufacturing digital trends to continuously improve system reliability and execution
• Clear communication skills, with the ability to explain technical concepts to both technical and non-technical partners and document work in a concise, understandable way

Qualifications

• Bachelor's degree in IT, Science, Technology, Engineering, or related field
• 1+ years of IT experience, software engineering, and/or digital capabilities, specifically experience working with Pharmaceutical Manufacturing Execution Systems, such as PMX, PharmaSuite, PAS-X, and/or Syncade, as well as WES/SAP
• Experience supporting/developing IT applications/solutions
• Hands-on experience with manufacturing operations and Manufacturing Execution Systems (MES), including implementation, integration, support, or optimization in a manufacturing environment

Preferred Qualifications

• Experience working in a GXP, regulated environment
• Experience maintaining Computer Systems Validation in line with pharmaceutical computer system quality regulations (e.g. cGMP’s, FDA 21 CFR Part 11) and other applicable regulations (e.g. privacy, OSHA, etc.)