Principal Process Engineer

Role Summary

Principal Process Engineer at Lilly, responsible for technical oversight and development/optimization of automated assembly processes within the Device and Packaging Manufacturing division. You will manage quality-direct impact systems, critical production components, and ensure reliable supply of manufactured products through production, testing, packaging, labeling, and storing activities. This role emphasizes technical leadership, problem-solving, and collaboration across functions to advance manufacturing excellence.

Responsibilities

• Technical Subject Matter Expert (SME) Oversight: Own equipment and packaging areas, possess deep knowledge of equipment and unit operation design characteristics on assembly and packaging lines; ensure equipment is maintained in its validated state (AQM); approve qualification scopes and re-qualification monitoring activities; review/approve significant changes or interventions for safety or quality impact.
• Innovation And Problem-Solving: Provide equipment and processing support for production issue resolution with data analysis and first principles applications; identify and drive improvement opportunities; participate in complex site investigations and CAPA planning to address events and prevent recurrence.
• Regulatory Compliance: Ensure adherence to regulatory requirements (cGMP, OSHA, environmental goals); support site inspection readiness and execution; interact with Regulatory Agencies during site inspections.
• Process Optimization: Develop local processes and procedures using lean tools; apply first principles to define scientific approaches for technical improvements; enhance process robustness, reduce variability, and improve uptime.
• Cross Functional Collaboration: Foster knowledge sharing and education within the team and with internal/external partners; integrate quality, technical services, and operations on projects and process improvements.
• Mentorship: Mentor and coach other technical resources on scientific/technical and business approaches; encourage safe idea sharing and risk awareness in decision-making.
• Safety And Quality Culture: Lead by example in safety and quality practices; author/review/approve GMP documentation including procedures, deviation investigations, design reviews, change controls, validation protocols, and summary reports.

Qualifications

• Required: Bachelor's Degree in Engineering, Science or related field.
• Required: 5+ years' experience in pharmaceutical manufacturing or regulated industry.
• Required: In-depth knowledge of GMPs, risk management, and process/equipment commissioning and qualification practices.
• Preferred: Prior experience in packaging and/or dry/wet device assembling operations.
• Preferred: Experience with asset design, delivery, and start-up.
• Preferred: Strong technical leadership and communication skills; ability to influence across disciplines and audiences.
• Preferred: Interpersonal and presentation skills to collaborate across diverse teams.
• Preferred: Ability to work independently and in teams; strong analytical and problem-solving abilities.

Education

• Bachelor's Degree in Engineering, Science or related field.

Additional Requirements

• Travel: Variable travel 0-50% depending on site and functional requirements.