Senior Engineer- Process Development​/NPI

Senior Engineer – Process Development/NPI

Join Amgen to apply for the Senior Engineer – Process Development/NPI role.

At Amgen, our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we have helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas—Oncology, Inflammation, General Medicine, and Rare Disease—we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller, happier lives.

Our award‑winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team.

In this role, you are a member of the Amgen Ohio Process Development organization. You serve as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. The NPI scope may include the implementation of various drug product formats (e.g., vial, syringe, auto‑injectors, etc.), introduction of new processes and equipment (including medical device final assembly and testing), and implementation of new packaging configurations.

You will engage drug product development teams throughout the commercialization process, leading multi‑functional NPI teams with support from Manufacturing, Supply Chain, Quality, Engineering, Capital Projects, Process Development and other business groups. Your primary responsibilities include leading NPIs for necessary process, facility, equipment, materials, and training modifications; developing project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordinating/executing NPI activities.

• Engage with network partners to develop process and technology strategies that achieve 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.

We seek an engineering professional who possesses the following 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

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well‑being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales‑based incentive plan
• Stock‑…