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.

Technical Subject Matter Expert (SME) Oversight:

• Demonstrate a strong ownership and stewardship for the device and packaging area you support by being flexible, proactive and involved.
• Liaise with regulatory function to align on regulatory strategies for new products, packaging, platform changes and planning for consolidated technical change agendas. Identify and lead the deployment of new technologies as appropriate.
• Engage externally to ensure the organization stays current in the evolving science, manufacturing technology, regulatory and compliance environment. Leverage these to improve strategies and applications for developing and controlling manufacturing processes.

• 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.

• 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.

Regulatory Compliance:

• Ensure adherence to current regulatory requirements, including c GMP standards, 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.

Process Optimization:

• 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, 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.

Cross Functional Collaboration:

• Foster knowledge sharing and education within the team and with key internal and external partners to drive alignment, share best practices, technical principles and meet manufacturing goals.
• Collaboratively integrate different disciplines such as engineering and analytical science on technical projects, process performance improvements, or control strategy effectiveness

Mentorship:

• Mentor and provide coaching to develop other technical resources on scientific approach, technology, as well as business approach and behaviors. This may include coaching on first principles, change or deviation management and processing issue resolution.
• Create a safe and encouraging environment for colleagues to share ideas, contribute and thrive
• Willingness to openly share, to speak up and ensure others understand the risks when making business choices and decisions.

Safety and Quality Culture:

• Lead by example in building and driving a culture of safety first and quality always within the organization.
• Author, Review and/or approve GMP documentation including procedures, deviation investigations, technical reports, change controls, regulatory submissions, validation protocols and summary reports, PFDs, APRs, etc.

• Demonstrated, strong technical leadership and communication skills. Communicates effectively across disciplines and types of audiences (internal and external) to influence and/or drive common understanding and appropriate actions.
• Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.
• Demonstrated, strong analytical and problem solving abilities.
• Familiarity with Commercialization process and Process Control requirements.

Additional preferences:

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.

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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