Engineer - IDM

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We're looking for people who are determined to make life better for people around the world.

Position Description:

Provide technical leadership starting in early device development phases to identify and define processes for manual and automated equipment used in support of new device assembly and packaging at Lilly and non-Lilly locations. Document technical studies in formalize technical reports.

Technically profile the methodologies and capabilities of the equipment venders to effectively support new line development and ongoing operations. Proactively introduce new process technology strategies and applications to maximize capital utilization and minimize time to volume. Work with management to assess, understand and develop OEM capabilities to better meet IDM needs.

Provide global leadership to Lilly sites, CM's, and OEMs to ensure equipment process development and designs meet Lilly requirements for quality, safety, cost, and time.

Support the global device network to develop process technology capabilities and synergistically leverage resources.

Key Objectives/ Deliverables:

Safety

Compliance to safe execution of CTC activities, including Lilly policies such as LOTO, safe work permits, and equipment design standards. Regular participation in safety audits for compliance and housekeeping. Ensure safe behaviors into lab and CTC pilot areas through frequent observations and interactions. Ensure HSE focus during equipment and process design and maintenance.

Commercialization Technology Center (CTC)

Build technical network with DDCS, EDG, ETC, and device network manufacturing sites. Work closely with IDM Engineering to develop and execute engineering, de-risking, proof of concept studies. Operate CTC equipment to build products for internal engineering studies and / or to support build requests from Lilly device development / asset delivery projects. Create maintenance action plans as needed to support maintenance and troubleshooting activities. Participate in periodic reviews of equipment state.

Process Development

Build and standardize process development systems, capabilities, and tools in partnership with DDCS and IDM SMEs. Support identification of key process risks via assessments and reviews. Utilize quality by design approaches in process development. Champion statistical thinking in experimental design and use of engineering first principles in process/equipment design and development. Implement standards and best practices for process engineering studies. Ensure appropriate level of quality in technical report documentation. Work with OEMs to develop and implement proof of concept technology assessments and technical studies, develop process documentation such as the process flow documents, document technical rationale for technology, OEM, and design decisions.

Product Commercialization

Identify key technologies and opportunities for commercialization platforms. Troubleshoot new applications of technology in support of capital project execution. Support the design of equipment for the commercialization agenda.

Technology and Technical Capability Development

Benchmark, develop, share, and implement new technology for device assembly in order to optimize value and reliability. Support development and delivery of technology to the device network. Profile and prioritize new technologies against current and future applications. Assess technical capabilities of original equipment manufacturers (OEM's). Design and implement lab and pilot scale equipment in order to de-risk high speed automated assembly processes.

People Development

Support the development of the device network technical capabilities. Build and utilize network of process/mechanical/electrical engineers at Lilly and outside. Coach and mentor CTC engineers and interns. Assist in mitigation of technical capability gaps inside the CTC.

Minimum Requirements:

• STEM Bachelor's degree or equivalent experience
• 5+ years of industry experience

Additional Preferences:

• Aptitude & interest to work with high speed, discreet electro-mechanical/process assembly equipment and related control system interfaces (design, fabrication & testing).
• Capability to work effectively across boundaries in a cross-discipline team (i.e. OEM's, contract manufacturers, Lilly sites, device network, etc.).
• Aptitude & interest to seek out and apply innovative automated assembly concepts to new applications.
• Proficiency to manage subtasks as part of larger projects.
• Familiarity with DOE's, GR&R's or process capability studies.
• Previous drug delivery, medical device or pharmaceutical industry experience.
• Education / experience working with development engineering on device design / assembly requirements interface (DFM/DFA)
• Working knowledge of GMP's, especially proficiency with process & equipment commissioning & qualification practices. Experience with Maximo and GMARS or similar computerized maintenance management system.
• Knowledge of device manufacturing processes, equipment, and manufacturing operations.
• Applicable advanced degree.
• Proficiency in French and/or German.

Other Information:

• Periodic Domestic and International Travel (average 5%)

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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).

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