About this role
Eli Lilly seeks a Process Engineer (R3-R4) to ensure safe design and operation of equipment, lead troubleshooting, and oversee CQV activities in pharmaceutical manufacturing.
Key Responsibilities
- Ensure safe equipment operation
- Lead troubleshooting
- Oversee CQV and qualification
- Develop test plans/protocols
- Assess impact on qualified state of equipment
Technical Overview
Role emphasizes validated systems (CQV), root cause analysis, test plans, equipment qualification, and safety-focused process engineering within Concord, NC.
Ideal Candidate
The ideal candidate is a mid-level process engineer with 5+ years in pharma manufacturing, CQV experience, and strong root cause analysis and testing capabilities to improve safety and equipment qualification.
Must-Have Skills
BS in Engineering / Computer Scienceor related fieldMinimum 5 years manufacturing experience in engineering or related functional area5 years experience with validated systems (CQV)5 years experience leading strategic projects related to safety improvements5 years experience creating and executing test plans and protocols for manufacturing5 years experience leading troubleshooting efforts5 years experience evaluating activities for impact on qualified state of equipment
Nice-to-Have Skills
Regulatory compliance knowledge (GMPOSHA)Computer System Validation (CSV) experienceDevice assembly/packaging experiencePharma manufacturing experienceCross-functional collaborationData systemshistoriansand reporting platforms
Tools & Platforms
CQVRoot Cause AnalysisTest Plans and ProtocolsManufacturing protocolsCQV lifecycle
Required Skills
Bachelor's degree in Mechanical EngineeringManufacturing EngineeringComputer Technology or related; 5 years experience with validated systems (CQV); root cause analysis; safety improvement projects; test plans and protocols; troubleshooting; equipment qualification
Hard Skills
BS in Engineering / Computer Scienceor related Science / Information Technology FieldAutomation engineeringIndustrial automationAutomation platformsComputer System ValidationCSVData systemsHistoriansRegulatory compliance (GMPOSHA)Project leadershipDocumentationLifecycle managementDevice packaging/assembly experiencePharma manufacturing experienceCross-functional collaboration
Soft Skills
leadershipcoachingcommunicationanalytical thinkingteam collaboration
Keywords for Your Resume
process engineerr3-r4concord ncpharmaceutical manufacturingcqvroot cause analysistest plansprotocolstroubleshootingequipment qualificationqualified state of equipmentsafety improvementsmanufacturing engineeringmechanical engineering5 yearsCQVprocess engineering
Deal Breakers
No 5+ years of relevant experience, Lack of CQV experience
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