Senior Engineer- Process Development/NPI

Career Category

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 benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• 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-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Apply now and make a lasting impact with the Amgen team.

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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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