Principal Process Engineer

Role Summary

Principal Process Engineer responsible for technical oversight and development and optimization of automated assembly processes within the Device and Packaging Manufacturing division. Focus on quality direct impact systems and critical components used in production, testing, packaging, labeling, and storing of manufactured products to maintain reliable supply for site-wide operations.

Responsibilities

• Technical Subject Matter Expert (SME) Oversight: Own equipment and packaging area, maintain validated state of equipment, approve qualification scopes, review changes and interventions for safety or quality impact.
• Innovation And Problem-Solving: Support production issue resolution with data analysis and first principles, drive improvements, participate in CAPA planning and implementation for safety and production events.
• Regulatory Compliance: Adhere to cGMP, OSHA, and environmental sustainability goals; participate in site inspections and readiness.
• Process Optimization: Develop local processes and procedures, apply lean tools, and use first principles to improve robustness, reduce variability, and improve uptime.
• Cross Functional Collaboration: Share knowledge with internal and external partners, align on best practices, and collaborate across quality, technical services, and operations on projects.
• Mentorship: Coach and develop other technical resources; foster a safe, inclusive environment for idea sharing and risk awareness.
• Safety And Quality Culture: Lead by example in safety and quality; author/review GMP documentation and related protocols and reports.

Qualifications

• 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

Additional Preferences And Information

• Prior experience in packaging and/or dry/wet device assembling operations
• Experience with asset design, delivery, and startup
• Awareness of PPE requirements in manufacturing environments
• Strong technical leadership, communication, and cross-disciplinary collaboration
• Excellent interpersonal and presentation skills; ability to work independently and in teams
• Strong analytical and problem-solving abilities
• Travel: 0-50% depending on site and functional requirements