About this role
Eli Lilly seeks a Systems Engineer to design, develop, and maintain MES software applications, acting as technical lead to integrate production processes with business systems for manufacturing efficiency and quality.
Key Responsibilities
- Design MES applications
- Develop and maintain MES software
- Lead technical MES integrations
- Ensure regulatory compliance
- Drive continuous improvement
Technical Overview
Role focuses on MES software design/maintenance, PharmaSuite, ISA-95/OPC standards, data historians, and MES cybersecurity, with FDA/GMP compliance oversight.
Ideal Candidate
The ideal candidate is a senior systems engineer with 5+ years designing and maintaining MES solutions in pharma manufacturing, strong ISA-95/OPC experience, and the ability to lead technical workstreams and collaborate across quality/compliance teams.
Must-Have Skills
Master's degree in Software EngineeringComputer Scienceor Computer Engineering5 years of experience with MES software solutions5 years of experience with PharmaSuite5 years of experience with MES standardsincluding ISA-95 and OPC5 years of experience with data historians for MES systems5 years of experience with cybersecurity as applied to MES technologies5 years of experience with identifying and resolving technical issues related to MES systemsconfigurationsand integrations
Nice-to-Have Skills
Regulatory compliance knowledge (GMPOSHA)Computer System Validation (CSV)Device packaging/assembly experience in pharmaPharma manufacturing or packaging experienceCross-functional collaboration with IT and manufacturingKnowledge of data systemshistoriansand reporting platformsTechnical expertise in automation platformscgmp regulatory knowledge
Tools & Platforms
PharmaSuiteOPCOPC UAData Historian platformsRegulatory/compliance tooling
Required Skills
Master's degree in Software EngineeringComputer Scienceor Computer EngineeringMES software solutionsPharmaSuiteISA-95OPCdata historianscybersecurity for MEStestingtroubleshootingregulatory compliance
Hard Skills
MESManufacturing Execution SystemPharmaSuiteISA-95OPCdata historianscybersecurity (MES)FDA guidelinesGMPtestingtroubleshootingdocumentationcontinuous improvementregulatory complianceMaster's degree in Software EngineeringMaster's degree in Computer ScienceMaster's degree in Computer Engineering
Soft Skills
leadershipproblem-solvingcommunicationteamworkcontinuous improvementanalytical thinkingdocumentation
Keywords for Your Resume
systems engineerR4-R6Manufacturing Execution SystemMESPharmaSuiteISA-95OPCdata historianscybersecurityFDA guidelinesGMPMaster's degreeregulatory compliancetestingtroubleshootingdocumentationcontinuous improvementmanufacturing operationspharma manufacturingMaster's degree in Software Engineering
Deal Breakers
No minimum 5 years MES experience, No master's degree in related field
Get matched to jobs like this
Luna finds roles that fit your skills and career goals — no endless scrolling required.
Create a Free Profile