Senior Engineer- Process Development/NPI

Role Summary

Senior Packaging Equipment Engineer- Process Development/NPI. Lead and manage Final Drug Product New Process Introductions (NPI) for Amgen Ohio, serving as project manager and technical expert. Coordinate multi-functional NPI teams to implement new processes, equipment, and packaging configurations, ensuring transfer to manufacturing and regulatory readiness.

Responsibilities

• Engage with network partners to develop process and technology strategies that meet development schedules while minimizing transfer risks.
• Collaborate with Combination Product Operations, Quality, and Regulatory to manage change control and respond to regulatory questions/audit findings within NPI scope.
• Generate, revise, review, execute, and approve technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, specifications).
• Ensure design/process transfer requirements are implemented and aligned with manufacturing strategies.
• Maintain a safe working environment by adhering to environmental health and safety practices and regulations.
• Lead and manage change control processes for NPIs, ensuring timely approvals and cross-functional implementation.
• Monitor and track NPI changes, conduct risk assessment, implement mitigation strategies, and align with project timelines.

Qualifications

• Basic Qualifications:
  • Doctorate degree
  • Or Master‚Äôs degree and 2 years of Process Development, Engineering, or NPI experience
  • Or Bachelor‚Äôs degree and 4 years of Process Development, Engineering, or NPI experience
  • Or Associate‚Äôs degree and 8 years of Process Development, Engineering, or NPI experience
  • Or High school diploma / GED and 10 years of Process Development, Engineering, or NPI experience

Skills

• Project management for NPI programs
• Process transfer and validation methodologies
• Document control and regulatory compliance
• Cross-functional collaboration across Manufacturing, Quality, Regulatory, and Engineering

Education

• Doctorate or Master‚Äôs/Bachelor‚Äôs/Associate‚Äôs/High school with relevant experience as specified in qualifications