Sr Principal Engineer

2 months ago

Indianapolis, United States Eli Lilly and Company Full time

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.

 

Position Brand Description:

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 Sr. Principal Engineer, you will provide technical oversight and will work to on the development and optimization of automated assembly processes. You will be accountable for technical aspects of quality direct impact systems and critical components used in production, testing, packaging, labeling, and storing of manufactured products to maintain the reliable supply for products across the site.

 

Key Objectives and Deliverables:

 

Technical Subject Matter Expert (SME) Oversight:

Demonstrate a strong ownership for the equipment and packaging area you support by being flexible, proactive and involved. Serve as a responsible engineer for site process lines by possessing a deep knowledge of equipment and unit operation design characteristics and capabilities on assembly and packaging lines. Ensure the equipment is maintained in its qualified state (AQM). Approve the scope of qualification and monitoring activities. Review and/or approve significant changes, maintenance, and other interventions for potential adverse impact on the safety or quality integrity of the equipment or process.

 

Innovation and Problem-Solving:

Provide equipment and processing support for production issue resolution and investigation with data analysis and first principles applications, ensuring reliable solutions, safe execution, and regulatory compliance. Identify and drive improvement opportunities. Support sites with complex investigation of key safety, quality, and production issues 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 cGMP standards, OSHA regulations, and environmental sustainability goals. Support site inspection readiness and execution. This role has direct interaction with Regulatory Agencies during site inspections.

 

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 improvements. Utilize in depth understanding of materials, process, and equipment to improve process robustness, reduce variability, and provide improvements in operational uptime and effectiveness.

 

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 quality, technical services, and operations on projects and process performance improvements

 

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, design reviews, change controls, validation protocols and summary reports, etc.

 

Minimum Qualifications:

Bachelor's Degree in Engineering, Science or equivalent field 8+ years' experience in pharmaceutical manufacturing or regulated industry In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices.

 

Additional Preferences:

Experience with asset design, delivery, and start up preferred. Prior experience in packaging and/or dry/wet device assembling operations. 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. Strong interpersonal and presentation skills with the ability to collaborate effectively across diverse teams and stakeholders. Ability to work well independently, as well as in teams. Provides partnership and collaboration across multiple disciplines.   Demonstrated, strong analytical and problem-solving abilities.

 

Additional Information:

Safety equipment (PPE) and precautions required in the manufacturing plant environment Travel may be required to support business needs. This is an onsite position that requires onsite presence the majority of the time.

 

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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