Contract Manufacturing Sr. 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.

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

• Provide technical engineering oversight for production processes for which they are responsible, ensuring stable supply of devices, subassemblies and components to Lilly sites.
• Lead prioritization of process changes necessary to maintain, sustain and improve the manufacturing process.
• Coordinate/lead cross-functional/cross-site/cross-company engineering project teams as needed.
• Develop effective and productive working relationships with colleagues at CM sites.
• Provide technical assessment of OEM Technical proposals and make recommendations as to OEM suitability.
• Support/lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
• Manage and coordinate shutdown scope activities at CM sites and ensure on-time Return to Service.
• 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. Assure testing is appropriately developed and is in accordance with the risk level of the item being tested.
• Define and mitigate technical and patient risks, including the use of FMEA/pFMEA.
• 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.
• 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.
• Participate on Commercialization project teams for new devices with focus on manufacturing readiness.

• Ensure Technical Stewardship projects to improve device design are prioritized within the Process Team agenda.

Minimum Experience Qualification Requirements:
• Minimum 3 years engineering experience, preferably in Manufacturing
• Demonstrated high degree of ownership / accountability
• Strong communication, teamwork, and networking skills
• Mechanical aptitude
• 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

Additional Preferences:
• Medical Devices experience preferred
• Experience with DOE and statistical methods as applied to engineering studies and reports
• Experience in capital project delivery and project management processes

Minimum Education Requirements:
BS in an Engineering or Engineering related field

Other Information (e.g., any required certifications):
Ability to participate in a short-term assignment (STA) for 6 to 12 months.

After STA, ability to travel 25% on average with peak over 50% for up to few months at a time

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national