Senior Engineer- Process Development/NPI

Career Category

Process Development

Job Description

Join Amgen’s Mission of Serving Patients

At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.

Since 1980, we’ve 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. Join us and transform the lives of patients while transforming your career.

Senior Packaging Equipment Engineer- Process Development/NPI

What you will do

Let’s do this. Let’s change the world. In this role you as a member of the Amgen Ohio, Process Development organization, this role serves as project manager and technical expert for Final Drug Product New Process Introductions (NPI) into Amgen Ohio. 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.

The Senior Engineer engages 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. Primary responsibilities include leading the NPI’s for necessary process, facility, equipment, materials, and training modifications; development of project execution plans; ensuring process requirements are effectively transferred into manufacturing; and coordination/execution of NPI activities, which may include document preparation or revision, change control management, manufacturing process modifications, equipment and technology implementation (design through qualification), and supporting manufacturing readiness activities. Work with various NPI support groups to develop, maintain, and implement the NPI project plan. Senior Engineer will function as the NPI project manager and is accountable for NPI scope, schedule, resources, and risk management. Responsibilities include issue resolution in a timely manner and partner concern to different levels of management as appropriate.

• 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.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek will possess these 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

What you can expect from us

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 ben