Lead MES Architect for GMP Gene Therapy Manufacturing

Eli Lilly and Company; Lebanon (IN); On-site; USD 129,000 - 211,000; Full time

Job summary

Eli Lilly and Company in Lebanon, Indiana seeks an experienced LP2 MES Technical Lead & Systems Architect to own end-to-end MES architecture. You will drive Tulip applications, SAP/PLM integrations, and validated migration from DEV to Production in a GMP setting.

You will collaborate with Operations, Automation Engineering, and Quality teams, mentoring MES engineers and ensuring ALCOA+/CSV compliance across the platform. This role is on-site in Lebanon, IN.

Qualifications

• Bachelor's degree in IT, Software/Computer Engineering or related field.
• 5+ years with MES or pharma IT platforms, including system integration (middleware/ERP/PLM) and Computer System Validation (CSV) in GMP settings.
• Authorized to work in the United States on a full-time basis; visa sponsorship is not provided.

Responsibilities

• Serve as Technical Lead/SME for LP2 MES architecture, design standards, and technical direction.
• Design, build, and validate Tulip applications for GxP manufacturing workflows and electronic batch records.
• Direct automation integrations with Automation Engineering (equipment commands, confirmations, process value subscriptions).
• Author/approve design specs ensuring ALCOA+ and 21 CFR Part 11 compliance.
• Guide components through validated migration lifecycle (DEV → QA → Production).
• Participate in Change Control Board (CCB) and ServiceNow change management.
• Partner with Manufacturing Operations, Automation Engineering, and Quality (BQA/CSQA).
• Mentor MES engineers; escalate complex issues when needed.
• Collaborate with MES Product Owner on ALM requirements/backlog.
• Report system status and technical risk to site/IT leadership.

Skills

Modern software architecture

MES integrations

Cross-functional comms

Git/GitHub

Jira

MUnit

MuleSoft/Anypoint

DataWeave

MQTT

OPC UA

eBRs/e-signatures

CSV validation

21 CFR Part 11

Education

Bachelor's degree in IT, Software/Computer Engineering or related field

Tools

MuleSoft/Anypoint

DataWeave

MQTT

OPC UA

Git

GitHub Actions

Jira

ServiceNow

MABL

Job description

Eli Lilly and Company in Lebanon, Indiana seeks an experienced LP2 MES Technical Lead & Systems Architect to own end-to-end MES architecture. You will drive Tulip applications, SAP/PLM integrations, and validated migration from DEV to Production in a GMP setting.

You will collaborate with Operations, Automation Engineering, and Quality teams, mentoring MES engineers and ensuring ALCOA+/CSV compliance across the platform. This role is on-site in Lebanon, IN.