Lilly Device Assembly & Packaging - Product Steward in Indianapolis, Indiana
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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.
Indianapolis Device Assembly and Packaging (IDAP) is the manufacturing site responsible for device assembly and packaging of products in the parenteral and dry product network. The Product Engineering team serves as the Technical Services / Manufacturing Sciences (TS/MS) function within IDAP Site. This team is expected to be the experts in regulatory, internal, and other requirements for device assembly operations, while ensuring that there is consistency in approach / processes across the site. The team also serves as primary liaisons between IDAP and upstream suppliers, both internal and external.
The TS/MS Product Steward is a technical leader of the TS/MS team at IDAP. This role is a technical position that supports, develops and implements a technical agenda, and is responsible for providing technical leadership across all processes and products within the IDAP site.
Primary objectives include maintaining the validated state of all IDAP processes, establishing metrics to ensure a state of capability and control, harmonization of control strategies across process teams, improvement of the processes, and serving as an escalation point for day to day operations issues for commercial products. Lastly, this role is expected to serve as a mentor to other employees within the IDAP TS/MS team.
Own the overall technical agenda for the IDAP site
Represent TS/MS team within IDAP Site Lead team on a regular frequency
Support TS/MS process team members
Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
Review and Approve, as required, relevant technical documents, such as: Annual Product Reviews, Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, etc.
Identify opportunities and lead technical projects to improve process control and/or productivity.
Drive technical consistency across IDAP process teams
Serve as technical interface with upstream groups
Serve as a technical mentor for engineers, Managers, and other disciplines.
Bachelor's degree or higher in engineering
5 years of experience in a manufacturing organization
Experience in Operations, Engineering, TS/MS
Root Cause Investigation Experience
Demonstrated successful leadership of cross-functional teams
Strong interpersonal and teamwork skills
Strong self-management and organizational skills
Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
Some travel (domestic and international) may be required
Position is located at the Lilly Technology Center – South campus
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).