Senior Engineer- Process Development/NPI
Amgen
Full-time
Remote friendly (New Albany, OH)
United States
Operations
Want to see how your resume matches up to this job? A free trial of our JobsAI will help! With over 2,000 biopharma executives loving it, we think you will too! Try it now — JobsAI.
Role Summary
Senior Packaging Equipment Engineer- Process Development/NPI
Responsibilities
- Engage with network partners to develop process and technology strategies that achieves clinical/commercial development schedules while minimizing transfer risks.
- Collaborate with Combination Product Operations, Quality, and Regulatory partners to manage change control processes and respond to regulatory questions and/or audit findings within the scope of the NPI.
- Support generation, revision, review, execution, and approval of relevant technical documents (e.g., manufacturing procedures, protocols, training materials, design control deliverables, and specifications).
- Ensure design/process transfer requirements are appropriately implemented and aligned with current manufacturing strategies.
- Support a safe working environment by staying in sync with all pertinent environmental health/safety practice, rules and regulations.
- Lead and manage change control processes for New Product Introductions (NPI), ensuring timely approvals, regulatory compliance, and seamless implementation across cross-functional teams.
- Monitor and track NPI-related changes to ensure proper risk assessment, mitigation strategies, and alignment 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
- Process Development
- New Process Introductions (NPI)
- Change Control
- Cross-functional leadership
- Documentation and design control
Education
- Doctorate, Master’s, Bachelor’s, Associate’s, or high school diploma with relevant experience as listed above
Additional Requirements
- None beyond listed qualifications