Lilly Engineering Devices- Process Leader in Augusta, Georgia
Title Engineering Devices- Process Leader
State / Province Georgia
Company Overview Elanco is a global research-based company that develops and delivers product and services to enhance animal health and production. We value innovation, both in scientific research and daily operations, and strive to cultivate a collaborative work environment for more than 7,000 employees worldwide. Founded in 1954, Elanco is a division of Lilly. Our worldwide headquarters and research facilities are in Greenfield, Indiana.
Responsibilities Engineering Devices- Process Leaderis responsible for managing day to day operations and providing technical input to manage supply, quality, and continuous process improvement of syringe components that are supplied to Elanco Augusta Technology Center.
Provide leadership of the Joint Process Team (JPT) between Augusta TS/MS, Quality, Engineering, Operations and component suppliers as it relates to delivery of syringe assembles barrel and plungers for site production
Build and drive a “safety first with quality always” culture in the Joint Process Team (JPT)
Provide technical oversight for production processes for which they are responsible, ensuring stable supply of components to Elanco Augusta Technology Center
Support all aspects of tool qualification, process validations and sterilization validation. Includes creation, execution and coordination of qualification and validation activities in partnership with Contract Manufacturers
Sponsor 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 data and completion of technical reports.
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.
Lead the resolution of manufacturing related issues, including deviations, evaluation of manufacturing data and supply chain coordination issues.
Ensure timely completion of documentation and process updates resulting from local procedural changes, audits, complaint investigations, documentation reviews, product reviews, process reviews and equipment.
Develop effective and productive working relationships with colleagues at Augusta Technology Center, Lilly IDM, and Contract Manufacturers
Lead cross-functional/cross-site/cross-company project teams as needed
Bachelor’s Degree: Engineering or related Technical degree
5 years in an Engineering, Operations Management or related field
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.
Demonstrated high degree of ownership/accountability
Strong Communication (written and oral) skills, teamwork, and influence
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
Demonstrated leadership skills through direct or indirect supervision of cross-functional teams
Understanding of GMP/QSR (21CFR820)/ISO 13485
Medical Device experience preferred
Travel require for Contract Manufacturing reviews
Position is located in Augusta, Georgia Elanco Augusta Technology Center
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.
Removal Date 23-Sep-2017