Process Engineer - Device Contract 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.

At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe 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.

Responsibilities:

• 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 crucial to maintain, sustain and improve the manufacturing process.

• Coordinate/lead multi-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.

• Lead 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 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.

• Assist 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.

Basic Qualifications:

• Bachelors in Engineering or technical related field (mechanical engineering preferred

• Minimum 2 years of manufacturing engineering experience (pharmaceutical/medical device experience preferred, open to other industries) ​

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

• Demonstrated high degree of ownership / accountability

• Strong communication, teamwork, and networking skills

• Mechanical proficiency

• Solid technical writing skills

• 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 Information:

• Ability to travel 25% on average with peak over 50% at times.

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.<