Organization and Position Overview
The Area Engineer serves as the site subject matter expert (SME) for the Logistics Buildings, Tank Farm, and associated ancillary systems within the FUME organization. Supports design, construction, commissioning, qualification, start-up, and operational readiness for Lilly Medicine Foundry logistics buildings and tank farm systems, and ensures systems are maintained in a compliant, reliable, cost-effective, fit-for-use state.
Responsibilities
- Serve as SME with deep technical expertise for assigned systems used in pharmaceutical manufacturing and support operations (including process flow diagrams, key process parameters, and industry trends).
- Ensure assigned processes align with industry requirements and Lilly standards; support risk assessment activities (e.g., FMEA).
- Lead or participate in projects/changes for logistics buildings and tank farm systems (design, IV/OV/PQ verification, user representation, local project delivery).
- Develop documentation (URS/test cases) and SOPs; contribute to resource assessments, capital plans, expense budgets, and prioritization.
- Monitor systems and maintain KPIs for compliance; act as single point of contact for compliance (deviations, change controls, CAPAs).
- Troubleshoot failures, lead root cause analysis (RCA), and guide issue resolution.
- Ensure corrective/preventive maintenance completion; support partner functions; manage capital projects (IQ/OQ/PQ) and inspections/investigations.
Basic Requirements
- Bachelorβs degree in Engineering (Mechanical Engineering/Technology or Chemical Engineering preferred).
- 5+ years direct engineering experience with building, utility, tank farm, and logistics-related systems in an FDA-regulated industry.
- Authorized to work in the U.S. full-time; Lilly does not sponsor visas.
Additional Preferences
- Start-up experience; agile engineering; equipment installation/commissioning/qualification.
- Experience with manufacturing/chemical plant utilities; engineering project management.
- CMMS, UBMS, QBMS; strong office software skills; communication skills.
- Knowledge of cGMP; ability to mentor/train.
Location
- Temporary: Carmel, Indiana. Permanent: Lilly Medicine Foundry in Lebanon, Indiana.