Senior Engineer- Process Development/NPI
Amgen
Full-time
Remote friendly (New Albany, OH)
United States
Operations
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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’s degree and 2 years of Process Development, Engineering, or NPI experience
- Or Bachelor’s degree and 4 years of Process Development, Engineering, or NPI experience
- Or Associate’s 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’s/Bachelor’s/Associate’s/High school with relevant experience as specified in qualifications