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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.
The purpose of this role is to provide injection molding expertise and support to the Elanco Augusta manufacturing operations and to interface with all functional groups inside and outside the Elanco Augusta site and Lilly Indy Device Manufacturing.
Product & Production Support:
Manage global injection mold tooling and molding ancillary equipment projects
Provide strategic leadership and develop network relationships to maximize effectiveness and efficiency for Elanco Augusta components
Provide technical injection molding expertise and guidance for mold design, validation and troubleshooting activities
Assure applicable regulatory and Elanco quality system requirements are met
Provide technical inputs for plastic components and assemblies to enhance mold, equipment, and/or part performance for pre-filled and reusable devices
Work with internal & external partners to develop potential product and process improvements.
Develop project alternatives to meet technical support needs, assisting in assessment and selection of improvement projects.
Troubleshoot and determine the root cause of device failures associated with injection molding and/or tooling.
Identify strategic areas for continued future improvements.
Oversee activities associated with periodic mold reviews at Contract Manufacturers. Analyze results and approve documents.
Support the implementation of Statistical Process Control for molded components
Quality System Compliance:
Ensure quality system and regulatory compliance
Supplier Relationship & Mgmt:
Develop successful business relationships and integrate external project team.
Provide assistance and oversight for injection molding, tooling, & ancillary equipment. Serve as a design and quality consultant to internal and external suppliers.
Compliance & Documentation:
Ensure that the work activities are conducted in accordance with applicable medical device regulations.
Follow good quality system practices and ensure documentation is developed that supports decisions and changes.
Review and approve validation plans, protocols, and individual mold validation summary reports to support project schedules.
Team work / Leadership / Communication:
Maintain frequent contact with the customers and suppliers and provide regular project updates.
Keep customers informed and satisfied with changes through network and communication.
Coaching and mentoring others
Bachelors Degree in Chemical, Mechanical, Plastics Engineering with 10 years of Injection Molding or Tooling Design experience
Bachelor’s degree (other), or trade (journeyman tool and dye maker, etc.) with 15+ years Injection Molding or Tooling Design experience
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.
Understanding of medical device and/or pharmaceutical validation and other related Regulatory requirements
Demonstrated high degree of ownership / accountability
Ability to work across boundaries (Elanco business partners, with equipment suppliers, parts suppliers, development team, etc)
Excellent written and oral communication skills including technical writing
Proven ability to organize and prioritize multiple tasks
Strong attention to detail
Ability to work independently as well as in a team environment
This positions will be located in Indianapolis Indiana
Domestic and international travel- 25- 50%
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.