Process Engineer - Indy Device Manufacturing Asset Delivery

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.

Organization Overview

Indianapolis Device Manufacturing (IDM) - Asset Deliver Process Engineering provide the technical leadership in developing, designing, constructing, and delivering/upgrading automated device assembly and packaging lines for IDM globally to both Lilly sites and Contract Manufacturers (CMO).

Responsibilities

IDM Asset Delivery Process engineers oversee the technical aspects of developing, designing, constructing, and delivering automated device assembly and packaging lines for IDM globally to both Lilly sites and Contract Manufacturers in support of new product launches, capacity expansions, and line extensions. In doing this, they function as the Technical Lead for the project. In addition, when primary support teams for the global installed base (CMO and Lilly sites) require assistance, these engineers provide assistance or leadership in returning lines to service or optimizing lines. 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.

• Lead the definition and mitigation of technical and patient risks, including use of FMEA
• Lead thorough design reviews to assure the design meets requirements and local/corporate standards
• Find and document opportunities to optimize line performance, leveraging the capital to generate more value
• 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
• Oversee the OEM's design process, assuring questions are resolved and barriers to progress are removed
• Lead the generation rationalization of user requirements for each project
• Lead the technical assessment of OEM technical proposals and make recommendations as to OEM suitability
• Lead characterization of unit operations and setting operating conditions by defining an Engineering Studies Plan, developing rigorous studies and executing them
• Assure each design includes maximum appropriate re-use of technology from prior projects

Basic Requirements

• BS in an Engineering (Mechanical, Chemical, or Biomedical Eng preferred)
• Experience in capital project delivery
• Experience dealing with design, startup, and/or operation of high-speed mechanical assembly lines
• Minimum 4 years engineering experience, preferably in manufacturing

Additional Skills

• Experience with engineering in a regulated pharmaceutical environment/cGMPs/Commissioning and Qualification
• Strong attention to detail
• Proven problem solving skills
• Experience with Medical Device assembly
• Experience with DOE, GR&R, Statistical methods as applied to engineering studies and reports
• Ability to lead and influence across organizational and company boundaries; ability to form relationships with others not in your organization
• Experience programming control systems for high-speed assembly lines
• Mechanical Aptitude
• Expertise in automation networks, vision systems for part inspection, debugging of assembly lines
• Proven ability to organize and prioritize multiple tasks
• Demonstrated high degree of ownership / accountability
• Strong communication, teamwork, and networking skills
• Expertise in process data historian configuration and/or use
• Ability to work independently as well as in a team environment
• Experience in large capital project delivery and management of sub-projects within a larger project
• Solid technical writing skills

Additional Information

• Ability to travel 25% on average, with peaks over 50% for a few months at a time

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