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Area Engineer – Small Molecule Building
Eli Lilly and Company. Serve as the site Subject Matter Expert for the Small Molecules building and associated ancillary systems within FUME .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing Small Molecules building systems and ensuring compliance with industry standards, while driving continuous improvement and operational readiness. Proficient in engineering project management, including installation, qualification, and maintenance of pharmaceutical manufacturing systems.
Highest-signal resume keywords
Bachelor's Degree In Engineering5+ Years Engineering Experience In FDA Regulated IndustryKnowledge Of cGMP PrinciplesExperience With CMMS, U/BMS And QMSStrong Technical Aptitude
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Engineering Project ManagementInstallation And Commissioning Of EquipmentRoot Cause AnalysisContinuous Improvement InitiativesRisk Assessments Including FMEADevelopment Of URS And Test CasesMonitoring KPIs For ComplianceTroubleshooting Equipment FailuresAgile Engineering TechniquesUnderstanding Of Engineering Concepts
Soft Skills
Excellent Interpersonal SkillsWritten And Verbal Communication SkillsAbility To Train And Mentor Others
Tools & Technologies
CMMSU/BMSQMSData HistorianOffice Software (Word, Excel, PowerPoint, Outlook)
Industry Keywords
Pharmaceutical ManufacturingSmall MoleculesCGMPFDA RegulationsChemical Equipment
About the role
Key responsibilities & impact- Serve as the site Subject Matter Expert for the Small Molecules building and associated ancillary systems within FUME
- Assist with design, construction, commissioning, qualification, start-up and operational readiness of systems during the project phase
- Oversee and maintain the Small Molecules building and ancillary systems during day-to-day operations
- Maintain systems in a compliant, in-control and fit-for-use state
- Drive continuous improvement initiatives and manage annual operating expenses and local capital investments
- Act as the single point of contact for Small Molecules building residents and customers
- Provide technical expertise for pharmaceutical manufacturing building systems and processes
- Ensure assigned processes align with industry and Lilly standards
- Support risk assessments, including FMEA
- Lead or participate in projects and changes, including design, verification, project management, resource planning, budget adherence and IQ/OQ/PQ activities
- Develop URS, test cases and other documentation for installation, qualification and start-up
- Contribute to resource assessments, capital plans and expense budgets
- Monitor systems and maintain KPIs for proper operation and compliance
- Coordinate deviations, change controls and CAPAs with Operations, Process Engineering, Supply Chain, HSE and Quality Assurance
- Implement maintenance and reliability techniques aligned with global engineering standards
- Troubleshoot equipment failures, perform root cause analysis and guide operations personnel
- Consult internal customers and provide notifications on critical utilities and equipment issues
- Track and ensure completion of corrective and preventive maintenance activities
- Provide technical assistance to FUME, HSE, Process Engineering and Operations personnel
- Support internal and external inspections and investigations
- Maintain effective communications with customer groups
Requirements
What you’ll need- Bachelor’s degree in Engineering (prefer ME, MET, Chem E)
- 5+ years of direct engineering experience of building, utility and chemical equipment related systems and their use in a manufacturing setting in an FDA regulated industry
- Previous start up experience for new building and chemical equipment related systems preferred
- Understanding of agile engineering techniques used in the management of buildings, utilities and equipment preferred
- Previous equipment installation / commissioning / qualification experience preferred
- Engineering experience with manufacturing / chemical plant utilities preferred
- Engineering related project management experience preferred
- Experience with CMMS, U/BMS and QMS preferred
- Demonstrated office software skills, including Word, Excel, PowerPoint, Outlook, UMS, data historian and collaboration sites
- Excellent interpersonal, written and verbal communication skills
- Knowledge of cGMP principles
- Demonstrated high level of understanding of engineering concepts, 1st principles and engineering functional standards
- Strong technical aptitude and ability to train and mentor others
- Must work at the temporary location in Carmel, Indiana, and permanent location in Lebanon, Indiana
Benefits
Comp & perks- Company bonus depending, in part, on company and individual performance
- Company-sponsored 401(k)
- Pension
- Vacation benefits
- Medical, dental, vision and prescription drug benefits
- Flexible benefits, including healthcare and/or dependent day care flexible spending accounts
- Life insurance and death benefits
- Certain time off and leave of absence benefits
- Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities