Technical Leadership for Device and Packaging Manufacturing

1 day ago

Marquand, Missouri, United States Eli Lilly Full time

At Eli Lilly, we are driven by a passion to improve the lives of people around the world. We are a global healthcare leader headquartered in Indianapolis.

Job Overview:

We are seeking a Sr Principal Engineer to join our Device and Packaging Manufacturing division. As a key contributor to our mission to deliver life-saving medications to patients worldwide, you will provide technical oversight and lead the development and optimization of automated assembly processes.

About this Role:

This role is accountable for ensuring the technical integrity of quality-critical systems and components used in production, testing, packaging, labeling, and storing of manufactured products. You will be responsible for maintaining a reliable supply chain across multiple sites.

Main Responsibilities:
  • Take ownership of equipment and packaging areas, demonstrating flexibility, proactivity, and involvement.
  • Evaluate and ensure the equipment is maintained in its qualified state (AQM).
  • Approve qualification and monitoring activities' scope.
  • Review and/or approve significant changes, maintenance, and interventions that could impact safety or quality integrity.
Innovation and Problem-Solving:
  • Collaborate with teams to resolve production issues and investigate complex problems using data analysis and first principles applications.
  • Identify opportunities for improvement and drive positive change.
  • Support sites in investigating key safety, quality, and production issues, and work on implementing CAPA plans to prevent recurrence.
Regulatory Compliance:
  • Evaluate adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals.
  • Assist with site inspection readiness and execution.
Process Optimization:
  • Develop local processes and procedures to enhance efficiency and effectiveness, utilizing lean tools for success.
  • Apply theoretical knowledge and first principles to define scientific approaches supporting technical improvements.
Cross Functional Collaboration:
  • Foster collaboration and knowledge sharing within teams and with internal and external partners to drive alignment, share best practices, and meet manufacturing goals.
  • Integrate different disciplines such as quality, technical services, and operations on projects and process performance improvements.
Mentorship:
  • Mentor and coach technical resources to develop scientific approach, technology, business approach, and behaviors.
  • Create an inclusive environment where colleagues can share ideas, contribute, and thrive.
Safety and Quality Culture:
  • Lead by example in building and driving a culture of safety first and quality always within the organization.
  • Audit, review, and/or approve GMP documentation including procedures, deviation investigations, technical reports, design reviews, change controls, validation protocols, and summary reports.
Minimum Qualifications:
  • Bachelor's Degree in Engineering, Science, or equivalent field.
  • 8+ years of experience in pharmaceutical manufacturing or regulated industry.
  • In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices.
Estimated Salary: $160,000 - $200,000 per year

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