Principal Process Engineer

Lilly • Indianapolis, IN

30d

About The Position

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 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. Embrace the challenge, seize the opportunity, and join us in shaping the future of manufacturing excellence at Eli Lilly!

Requirements

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

Nice To Haves

• Prior experience in packaging and/or dry/wet device assembling operations.
• Experience with asset design, delivery, and start up preferred.
• Safety equipment (PPE) and precautions required in the manufacturing plant environment.
• 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.
• Variable travel of 0-50% plus could be expected based upon specific site and functional requirements.

Responsibilities

• 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 validated state (AQM).
• Approve the scope of qualifications and re-qualification 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 with complex sites investigation of key safety and production 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 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.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees