Lilly Automation Engineer-Device Manufacturing in Indianapolis, Indiana
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.
Indy Device Manufacturing (IDM) is an external facing team responsible for the manufacturing of medical devices and the delivery of the custom assembly equipment utilized as part of the manufacturing process. Automation engineers oversee the technical aspects of developing, designing, constructing, and delivering automated device assembly lines for IDM globally to both Lilly sites and Contract Manufacturers in support of new product launches, capacity expansions, and line extensions. Automation engineers in IDM work closely with Original Equipment Manufacturers (OEM) to design and build custom medical device assembly machines. These engineers also develop and implement best practices for design and startup of device assembly lines and deploy systems to capture and utilize process data.
Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability
Support all aspects of tool and process validations including computer system validation. Includes creation, execution and coordination of validation activities in partnership with Contract Manufacturers.
Manage the generation rationalization of user requirements for each project
Define and mitigate technical and patient risks, including use of FMEA
Assure each design includes maximum appropriate re-use of technology from prior projects
Oversee OEM's design process, assuring questions are resolved and barriers to progress are removed
Conduct thorough design reviews to assure design meets requirements and local/corporate standards
Characterize unit operations and set operating conditions as required by defining an Engineering Studies plan, developing rigorous studies and executing them
Assure testing is appropriately developed and is in accordance with the risk level of the item being tested
Document research and investigations as technical reports
Complete engineering activities involved in the development of process/product improvements. This includes project planning activities, development of protocols, coordination of internal and external lab based testing, documentation of the data and completion of technical reports.
Work with external companies and project teams to develop product and process improvements.
Ensure that the processes, facilities, equipment, or systems for which they are responsible are compliant, capable, in control, and maintained in a validated or qualified state.
Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
Participate on Commercialization project teams for new devices with focus on manufacturing readiness.
Lead cross-functional/cross-site/cross-company project teams as needed.
Identify and implement process and product changes necessary to maintain, sustain and improve the manufacturing process.
Support Technical Stewardship projects to improve device design.
BS in an Engineering or Engineering related field
Minimum 2 years engineering experience, preferably in Manufacturing
Medical Devices experiences preferred
Experience with DOE and statistical methods as applied to engineering studies and reports
Experience in large capital project delivery and management of sub-projects within a larger project
Demonstrated high degree of ownership / accountability
Experience with engineering in a regulated pharmaceutical environment/cGMPs/Commissioning and Qualification
Experience in programming control systems for high-speed assembly lines
Strong communication, teamwork, and networking skills
Expertise in automation networks, vision systems for part inspection, debugging of assembly lines
Solid technical writing skills
Proven ability to organize and prioritize multiple tasks
Strong attention to detail
Proven problem solving skills
Ability to work independently as well as in a team environment
- Ability to travel 25% on average with peak over 50% for a few months at a time
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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).