Principal Engineer - Indianapolis, United States - Eli Lilly

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 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.

In 1992, Eli Lilly and Company established the delivery device business for the purpose of designing, developing, launching, and continuously improving proprietary delivery device systems. This business is unique to the broader Lilly Research Labs (LRL) organization due to its focus on patient-centered delivery system solutions, its new way to design and develop delivery platforms utilizing both internal and external technologies, and its level of integration with the commercial groups and Business Units. The Delivery Device Connect Solutions (DDCS) organization leverages alliances in design and manufacturing to rapidly convert proprietary concepts into products that meet the users' needs and intended uses.

In response to a rapidly growing development pipeline and commercial portfolio, DDCS is seeking a Principal Engineer within the Packaging Systems team. You will be an individual contributor in our IMPACTS (Imaging, Material, Performance, Analytical, Container Closure Integrity, Transportation and Surface Science) lab area supporting drug product R&D efforts specifically focused on container closure and device characterization. You should have significant experience in container closure integrity testing (CCIT) for sterile products and a solid foundational understanding of deterministic and probabilistic test methods and their application for R&D and commercial control strategy development. Additional experience using any of the following analytical techniques to characterize and evaluate container closure / device component attributes and system performance is highly desirable including: materials testing, mechanical testing, microscopy, and/or x-ray computed tomography (CT) imaging. You should be able to analyze, interpret, and communicate data to stakeholders and drive execution across multiple projects and programs. We are seeking a highly motivated individual with the ability to impact the following areas:

Drug Product / Device Development and Commercialization

• Deliver timely, high-quality data by effectively driving project execution with minimal guidance.
• Demonstrate a working knowledge of engineering first principles and the ability to apply them to packaging and device applications.
• Identify and evaluate new analytical testing technologies especially in the field of CCIT and develop test methods to improve lab capabilities.
• Understand, influence, and lead the execution of experimental design activities to demonstrate container closure systems / devices meet regulatory requirements and specifications to speed decision making.
• Actively participate in laboratory ownership responsibilities and remain compliant with the laws, regulations, guidelines, procedures and safety practices governing drug product and device research and development to maintain Lilly's "Safety First, Quality Always" mindset.

Cross Functional Collaboration and People Development

• Have excellent interpersonal / team building skills and maintain a track record of building collaborative scientific relationships.
• Ability to grow into a technical mentor by partnering with the management team to develop organizational talent.
• Interact across groups, including equipment / component suppliers, external testing labs, regulatory agencies, and other functional business areas to communicate packaging strategy, risks, timing, and cost.
• Effectively communicate project goals and progress at governance committees and other LRL forums.
• Participate in collaborations, research agreements, and outsourcing with world class external partners with interest in increasing personal involvement in activities (e.g., publishing or presenting at external conferences, participation in external standards organizations) to enhance the brand reputation for LRL and DDCS.

Basic Qualifications:

• B.S. or M.S. in Chemistry, Biochemistry, Engineering, Materials Science, or other relevant fields with 5-10+ years of experience in pharmaceutical packaging / science / medical devices
• Prior experience working in a research laboratory setting developing or executing analytical test methods to characterize pharmaceutical materials / container closure systems / medical devices.

Additional Skills and Preferences:

• Working knowledge of pharmaceutical industry regulatory directives, guidance, and compendia standards for packaging components, container closure systems (e.g. FDA, Ph.Eur, USP, WHO), or medical devices.
• Self-management skills with a focus on results for timely and accurate completion of competing deliverables
• Strong technical writing skills and effective communication style.
• Strong technical problem-solving skills, strategic thinking, and demonstrated ability to identify problems and drive issue resolution / improvements.
• Experience using any of the following analytical techniques to characterize and evaluate container closure / device component attributes and system performance is highly desirable including: materials testing, mechanical testing, microscopy, and dimensional measurement.

Additional Information:

• Position Location: Indianapolis, IN Lilly Technology Center-North
• Travel 10% both US and OUS

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 ( ) 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.

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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.

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