Sr. Principal Scientist - TS​/MS Device & Packaging

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.

Join us at Eli Lilly in a dynamic role where you'll be a pivotal force in our Device and Packaging Manufacturing division, supporting our mission to deliver life-saving medications to patients worldwide. As a Specialist in Technical Services/Manufacturing Sciences (TS/MS), you will provide technical oversight and will work to deliver successful approaches for new and existing medicines introduced on lines, support technical transfer, and optimize existing control and capacity to maintain the reliable supply for products across the site.

• Demonstrate a strong ownership and stewardship for medical device design, manufacturing, labelling, and/or packaging processes you support by being flexible, proactive and involved.

• Liaise with regulatory function to align on strategies for new products, packaging, platform changes and planning for consolidated technical change agendas. Understand key regulations and their impact to the medical device design transfer and post-launch surveillance process.

• Engage externally to ensure the organization stays current in the evolving risk management, state-of-the-art technology, regulatory and compliance environment. Leverage these to improve strategies and applications for developing and controlling design transfer and manufacturing processes.

• Prepare, review, and approve study designs, protocols, technical reports, and other related technical documentation. Oversee qualification and validation strategy for device and packaging processes.

• Independently identify the key engineering questions/issues and develops solutions to advance business objectives.

• Provide technical and effective process support services for production issue resolution and investigation with proficient data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance.

• Identify and drive improvement opportunities. Implement the organization’s technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities.

• Support complex investigation of key issues and events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence.

• Ensure adherence to current regulatory requirements, including cGMP standards, ISO 14971, ISO 11608, OSHA regulations, and environmental sustainability goals.

• Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.

• Identify weaknesses and opportunities in control strategy and pursue improvements and resolution.

• Establish guidance and standards for critical aspects of the operational and equipment control strategy supporting device and packaging platforms.

• Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.

• Use first principles and theoretical knowledge to define scientific approaches to support technical expectations. Utilize in depth understanding of materials, process, automation, and product to improve. product/process robustness, reduce variability, and provide improvement in control strategies.

• Perform process monitoring of critical parameters and react to signals/trends to drive continuous improvement, process capability and prevention of issues.

• Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment, share…