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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 39,000 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.
As a Quality Control Engineer you will act as a program owner for Engineering Studies which are used to assess the capabilities of equipment and devices used in device manufacturing processes. You will develop common templates, methodologies, and training materials to ensure studies are effectively designed and executed. Your review, analyze and summarized results of studies will determine final capabilities of equipment and devices.
In this role, you will technically profile the methodologies and capabilities of the equipment vendors to effectively support new line development and ongoing operations. You will work with management to assess, understand and develop OEM capabilities to better meet Device Manufacturing needs.
You will provide technical leadership in early device manufacturing equipment development to identify and define processes for manual and automated equipment used in the support of new device assembly and packaging at Lilly and non-Lilly locations. Addition you will 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.
Program Ownership/Process Development
Utilize Quality by Design approaches in process and engineering study development.
Champion statistical thinking in experimental design and use of engineering first principles in process/equipment/study 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
Support identification of key process risks via assessments and reviews (i.e. FMEA, Design Safe, etc.)
Technology and Technical Capability Development
Support the assessment of technical capabilities for original equipment manufacturers (OEM’s).
Support design and implementation of lab and pilot scale equipment in order to de-risk high speed automated assembly processes.
Support the development of the device network technical capabilities.
Build and utilize a network of process/mechanical/electrical engineers at Lilly and outside.
Coach and mentor engineers and interns.
Assist in mitigation of technical capability gaps across projects.
Bachelor of Science, engineering (mechanical or electrical preferred) or relevant scientific discipline with 5+ years of experience in automated assembly or a related manufacturing environment
Associate Degree, engineering (mechanical or electrical preferred) or relevant scientific discipline with 10+ years of experience in automated assembly or a related manufacturing environment
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Aptitude & interest to work with high speed, discreet electro-mechanical/process assembly equipment and related control system interfaces (design, fabrication & testing).
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 methods for testing device and equipment capabilities.
Proficiency to manage subtasks as part of larger projects.
Familiarity with DOE’s, GR&R’s or process capability studies, and Statistical tools and methods for assessing studies
Previous drug delivery, medical device or pharmaceutical industry experience.
Working knowledge of GMP’s, especially proficiency with process & equipment commissioning & qualification practices.
Knowledge of device manufacturing processes, equipment, and manufacturing operations.
Applicable advanced degree.
American Society for Quality (ASQ) certification or Certified Quality Engineer
Travel – Periodic extensive domestic & international travel (could be up to 25% in certain periods of time as driven by project needs)
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.