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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$123,750 - $198,000

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:

Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) leads all aspects of the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. The QA Representative - Commissioning and Qualification provides quality oversight and support for medical devices and combination products during technical transfer to contract manufacturing operations.

Provide technical leadership starting in early device development phases to identify and define processes for manual and automated equipment used in support of new device assembly and packaging at Lilly and non-Lilly locations.  Document technical studies in formalize technical reports. Technically profile the methodologies and capabilities of the equipment venders to effectively support new line development and ongoing operations.  Proactively introduce new process technology strategies and applications to maximize capital utilization and minimize time to volume.  Work with management to assess, understand and develop OEM capabilities to better meet IDM needs. Provide global SME leadership to Lilly sites, CM’s, and OEMs to ensure equipment process development and designs meet Lilly requirements for quality, safety, cost, and time. Provide safety hazard assessment leadership for new equipment throughout phases of asset delivery. Support the global device network to develop process technology capabilities and synergistically leverage resources.

Key Objectives/ Deliverables:

Safety:

Compliance to safe execution of CTC activities, including Lilly policies such as LOTO, safe work permits, and equipment design standards.

Participate in asset delivery equipment hazard assessments.

Regular participation in safety audits for compliance and housekeeping. 

Ensure safe behaviors into lab and CTC pilot areas through frequent observations and interactions.

Ensure HSE focus during equipment and process design and maintenance.

Commercialization Technology Center (CTC):

Build technical network with DDR&D, EDG, ETC, and device network manufacturing sites.

Work closely with IDM Engineering to develop and execute engineering, de-risking, proof of concept studies. 

Operate CTC equipment to build products for internal engineering studies and / or to support build requests from Lilly device development / asset delivery projects. Create maintenance action plans as needed to support maintenance and troubleshooting activities. Participate in periodic reviews of equipment state.

Process Development:

Build and standardize process development systems, capabilities, and tools in partnership with DDR&D and IDM SMEs. 

Support identification of key process risks via assessments and reviews. 

Utilize quality by design approaches in process development.

Champion statistical thinking in experimental design and use of engineering first principles in process/equipment design and development. 

Implement standards and best practices for process engineering studies. Ensure appropriate level of quality in technical report documentation. 

Work with OEMs to develop and implement proof of concept technology assessments and technical studies, develop process documentation such as the process flow documents, document technical rationale for technology, OEM, and design decisions. 

Product Commercialization:

Identify key technologies and opportunities for commercialization platforms. 

Troubleshoot new applications of technology in support of capital project execution.

Support the design of equipment for the commercialization agenda.

Technology and Technical Capability Development:

Benchmark, develop, share, and implement new technology for device assembly in order to optimize value and reliability.

Support development and delivery of technology to the device network. Profile and prioritize new technologies against current and future applications. 

Assess technical capabilities of original equipment manufacturers (OEM’s).

Design and implement lab and pilot scale equipment in order to de-risk high speed automated assembly processes.

People Development:

Support the development of the device network technical capabilities.

Build and utilize network of process/mechanical/electrical engineers at Lilly and outside.

Coach and mentor CTC engineers and interns.

Assist in mitigation of technical capability gaps inside the CTC.

Minimum Requirements:

Bachelor of Science, engineering or equivalent (preferably mechanical or electrical)

5+ years of experience in automated assembly or a related manufacturing environment

Additional Preferences:

Aptitude & interest to work with high speed, discreet electro-mechanical/process assembly equipment and related control system interfaces (design, fabrication & testing).

Equipment hazard assessment experience.

Capability to work effectively across boundaries in a cross-discipline team (i.e. OEM’s, contract manufacturers, Lilly sites, device network, etc.).

Aptitude & interest to seek out and apply innovative automated assembly concepts to new applications.

Proficiency to manage subtasks as part of larger projects.

Familiarity with DOE’s, GR&R’s or process capability studies.

Previous drug delivery, medical device or pharmaceutical industry experience.

Experience working with development engineering on device design / assembly requirements interface (DFM/DFA) Working knowledge of GMP’s, especially proficiency with process & equipment commissioning & qualification practices.

Experience with Maximo and GMARS or similar computerized maintenance management system.

Knowledge of device manufacturing processes, equipment, and manufacturing operations. Applicable advanced degree.

Proficiency in French and/or German.

Other Information:

Travel – Periodic extensive domestic & international travel (could be up to 25% in certain periods of time as driven by project needs)

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 an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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