Senior Engineer- Process Development​/NPI

Senior Engineer – Process Development / NPI

Columbus, OH

Join Amgen’s mission of serving patients. 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 have helped pioneer the world of biotech in our fight against the world’s toughest diseases. With a focus on 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.

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

• 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 practices, rules, and regulations.
• Lead and manage change control processes for NPIs, 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.

The engineering professional we seek will possess the following qualifications.

• Doctorate degree
• Masters degree and at least 2 years of Process Development, Engineering, or NPI experience
• Bachelor’s degree and at least 4 years of Process Development, Engineering, or NPI experience
• Associate’s degree and at least 8 years of Process Development, Engineering, or NPI experience
• High school diploma / GED and at least 10 years of Process Development, Engineering, or NPI experience

We support your professional and personal growth and well‑being with competitive benefits and a collaborative culture. 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, comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save for retirement, work/life balance initiatives, and career development opportunities.

• A comprehensive employee benefits package, including a retirement and savings plan, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program
• Stock‑based long‑term incentives
• Award‑winning time‑off plans
• Flexible work models, including remote and hybrid arrangements where possible

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 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.

Mid‑Senior level

Full‑time

Engineering and Information Technology

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