Process Engineer – Indy Device Manufacturing

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 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 Title:

Process Engineer – Indy Device Manufacturing

Job Level: P1 – P4

Functional Unit:
Engineering

Supervisor

Title:

Manager, Process Engineering – Indy Device Manufacturing (IDM)

Organization Overview:

At Lilly, we serve an extraordinary purpose. We make a difference for people around the global by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.

Position Brand

Description:

The position is responsible for working with Contract Manufacturer(s) (CM) and Original Equipment Manufacturer (OEM) to support, supply, quality, and continuous process improvement of delivery devices, sub‑assemblies, and components that are supplied to Lilly packaging and manufacturing sites.

Responsibilites:

• Provide technical oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
• 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.
• Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
• Support the timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
• 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.
• Ensure timely completion of documentation and process updates resulting from local and global procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment reviews.
• Lead prioritization of process and product changes necessary to maintain, sustain and improve the manufacturing process.
• Ensure…