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Lilly Device Assembly & Packaging - Product Steward in Indianapolis, Indiana

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 35,000 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.

Organization Overview:

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.

Responsibilities:

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.

Basic Requirements:

  • Bachelor's degree or higher in engineering

  • 5 years of experience in a manufacturing organization

Additional Skills/Preferences:

  • 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

Additional Information:

  • Some travel (domestic and international) may be required

  • Position is located at the Lilly Technology Center – South campus

Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. 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.

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).

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