Consultant Engineer-Packaging Steward

Company: Eli Lilly and Company
Location: Indianapolis
Posted on: June 12, 2021

Job Description:

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.

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.

Position Brand Description:

The Engineer - Packaging Steward is a technical position that develops and implements a technical agenda, and is responsible for providing technical leadership for Packaging TS/MS activities within IDAP - including cleaning validation. Primary objectives include reliable and compliant manufacturing of IDAP products and improvement of the process control strategy and validation strategy. The scope of the role includes currently marketed products and new production assets impacting packaging. While this role is not expected to be the technical expert on all products and platforms, it is expected to be the expert in regulatory, internal, and other requirements. A key part of this role is ensuring that there is consistency in approach / processes, as well as acting as a primary liaison with network-level Cleaning Validation experts . Lastly, this role is expected to serve as a mentor to other employees within the IDAP TS/MS team.

Key Objectives / Deliverables:

• Serve as a technical mentor for Scientists, Managers, and other disciplines.
• Provide technical support to non-routine (e.g., deviation, complaint) investigations, including consultation on quality and stability issues.
• Drive the Process and Cleaning Validation agenda across the IDAP site
• Identify opportunities for best practices, and implement improvements to tech transfer business processes
• Prepare, Review and Approve, as required, relevant technical documents, such as: Change Controls, Regulatory Submissions, Deviations, Validations, Procedures, PFDs, etc.
• Lead technical projects to improve process control and/or productivity.
• Drive stability strategy for packaged products
• Drive technical excellence through meaningful specifications - including approval of local specifications and influencing global specifications
• Drive technical consistency in tech transfer deliverables
• Provide technical guidance to Tech Transfer teams, as needed
• Own a technical agenda for a product or validation process.

Minimum Requirements:

• BS or MS in engineering, or other related scientific discipline
• Experience in Cleaning Validation

Additional Preferences:

• Experience in Operations, TS/MS, or Engineering
• Cleaning Validation Experience
• Demonstrated successful leadership of cross-functional teams
• Overall knowledge of control strategy for packaging
• 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

Education Requirements:

BS or MS in engineering, or other related scientific discipline

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 ( Lilly_Recruiting_Compliance@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.

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