MES Systems Engineer
Eli Lilly and Company
2 hours ago
On-site
Indianapolis, IN
IT
MES Systems Engineer
What You’ll Be Doing
- Support and evolve manufacturing execution systems at the Indy Parenteral Manufacturing (IPM) site.
- Translate manufacturing processes into system requirements, electronic Master Batch Records (MBRs), and MES solutions that meet quality, compliance, and operational needs.
- Support current MES platform PMX (design, configuration, validation, deployment, ongoing support of electronic MBRs and related MES functionality).
- Plan and execute transition to PharmaSuite (next-generation MES platform).
- Participate across the solution lifecycle (requirements gathering, system design, testing, validation, production support) and drive MES integration with manufacturing, warehouse, and IT systems.
- Design and enable safe, efficient pharmaceutical manufacturing via MES and Digital Execution solutions.
- Provide hands-on support, troubleshoot equipment/software/network issues, and diagnose/resolve issues to minimize downtime.
- Partner with Engineering, Operations, Quality, and IT to investigate issues, identify root causes, and implement sustainable solutions.
- Incorporate security, data integrity, and compliance into system designs; communicate with technical/non-technical stakeholders.
- Support adoption of digital solutions with business SMEs; collaborate with technical experts to balance usability, performance, and maintainability.
- Participate in review/approval of validation and lifecycle documentation (e.g., SOPs, protocols, system records).
What You Should Bring
- Experience supporting MES (PMX and/or PharmaSuite), translating manufacturing needs into system requirements/configurations/electronic batch record (eMBR) updates.
- Exposure to or interest in MES platform transitions (PMX → PharmaSuite migration).
- Experience with computer system validation (CSV), including test execution/documentation and data integrity expectations.
- Ability to gather/document non-functional requirements (performance, security, usability, data integrity, reliability) and implement solutions.
- Hands-on troubleshooting for MES-related issues (application behavior, system interfaces, connectivity) with a root-cause focus.
- Strong cross-functional collaboration (Operations, Engineering, Quality, IT); secure and compliant system use.
- Exposure to reporting/dashboards/manufacturing data flows and data continuity as systems modernize.
- Experience supporting project execution (task tracking, status updates, coordination).
- Growth mindset and clear communication/documentation skills.
Basic Qualifications
- Bachelor’s in IT, Science, Technology Engineering, or related field.
- 1+ years of IT/software engineering/digital capabilities; experience with pharmaceutical MES (PMX, PharmaSuite, PAS-X, Syncade) and WES/SAP.
- Experience supporting/developing IT applications/solutions.
- Hands-on manufacturing operations and MES experience (implementation, integration, support, or optimization).
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas.
Preferred Qualifications
- Experience in a GXP, regulated environment.
- Experience maintaining Computer Systems Validation aligned with pharmaceutical regulations (e.g., cGMPs, FDA 21 CFR Part 11) and other applicable regulations.
Benefits (if explicitly provided)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.
Additional Information
- Position based in Indianapolis, Indiana.
- 8-hour days; possible after-hour support.
- On-site presence minimum 4 days/week; occasional travel may be required.
- Must maintain a safe work environment and support health and safety goals.
What You’ll Be Doing
- Support and evolve manufacturing execution systems at the Indy Parenteral Manufacturing (IPM) site.
- Translate manufacturing processes into system requirements, electronic Master Batch Records (MBRs), and MES solutions that meet quality, compliance, and operational needs.
- Support current MES platform PMX (design, configuration, validation, deployment, ongoing support of electronic MBRs and related MES functionality).
- Plan and execute transition to PharmaSuite (next-generation MES platform).
- Participate across the solution lifecycle (requirements gathering, system design, testing, validation, production support) and drive MES integration with manufacturing, warehouse, and IT systems.
- Design and enable safe, efficient pharmaceutical manufacturing via MES and Digital Execution solutions.
- Provide hands-on support, troubleshoot equipment/software/network issues, and diagnose/resolve issues to minimize downtime.
- Partner with Engineering, Operations, Quality, and IT to investigate issues, identify root causes, and implement sustainable solutions.
- Incorporate security, data integrity, and compliance into system designs; communicate with technical/non-technical stakeholders.
- Support adoption of digital solutions with business SMEs; collaborate with technical experts to balance usability, performance, and maintainability.
- Participate in review/approval of validation and lifecycle documentation (e.g., SOPs, protocols, system records).
What You Should Bring
- Experience supporting MES (PMX and/or PharmaSuite), translating manufacturing needs into system requirements/configurations/electronic batch record (eMBR) updates.
- Exposure to or interest in MES platform transitions (PMX → PharmaSuite migration).
- Experience with computer system validation (CSV), including test execution/documentation and data integrity expectations.
- Ability to gather/document non-functional requirements (performance, security, usability, data integrity, reliability) and implement solutions.
- Hands-on troubleshooting for MES-related issues (application behavior, system interfaces, connectivity) with a root-cause focus.
- Strong cross-functional collaboration (Operations, Engineering, Quality, IT); secure and compliant system use.
- Exposure to reporting/dashboards/manufacturing data flows and data continuity as systems modernize.
- Experience supporting project execution (task tracking, status updates, coordination).
- Growth mindset and clear communication/documentation skills.
Basic Qualifications
- Bachelor’s in IT, Science, Technology Engineering, or related field.
- 1+ years of IT/software engineering/digital capabilities; experience with pharmaceutical MES (PMX, PharmaSuite, PAS-X, Syncade) and WES/SAP.
- Experience supporting/developing IT applications/solutions.
- Hands-on manufacturing operations and MES experience (implementation, integration, support, or optimization).
- Must be authorized to work in the United States full-time; Lilly does not sponsor visas.
Preferred Qualifications
- Experience in a GXP, regulated environment.
- Experience maintaining Computer Systems Validation aligned with pharmaceutical regulations (e.g., cGMPs, FDA 21 CFR Part 11) and other applicable regulations.
Benefits (if explicitly provided)
- Eligibility for company bonus; comprehensive benefits including 401(k), pension, vacation, medical/dental/vision/prescription, flexible benefits, life insurance, time off/leave of absence, and well-being benefits.
Additional Information
- Position based in Indianapolis, Indiana.
- 8-hour days; possible after-hour support.
- On-site presence minimum 4 days/week; occasional travel may be required.
- Must maintain a safe work environment and support health and safety goals.