Engineer Process Development Environmental & Contamination Control

Engineer Process Development Environmental & Contamination Control

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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions.

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.

What You Will Do

Let's do this. Let's change the world. In this vital role, you will join the Process Development team in a highly matrixed environment supporting commercial programs at the Amgen Rhode Island site. You will work with a cross-functional team of engineers and scientists to provide technical process support for technology transfer, process performance qualification, continued process monitoring, and deviation resolution for both existing products and new product introductions with a primary focus on environmental contamination control.

The site operates two multiproduct facilities that manufacture a diverse portfolio of innovative biologic and biosimilar medicines.

This role offers strong opportunities for career growth and professional development. You will strengthen your leadership, teamwork, and communication skills while building influence across Process Development, Manufacturing, Quality, and Information Systems. The position also provides broad exposure to the technical and operational aspects of a commercial bulk drug manufacturing facility.

Core Responsibilities

• Work in partnership with manufacturing, engineering and quality to fulfill key objectives specific to Environmental Contamination Control (ECC).
• Provide real-time technical support to manufacturing operations to meet production schedules and resolve complex process issues.
• Monitor process performance and operational trends, identify opportunities for improvement, and recommend effective troubleshooting strategies.
• Apply engineering principles, statistical analysis, and design of experiments to investigate processing issues and drive process optimization.
• Collaborate effectively with Manufacturing, Process Development, Quality, and other cross-functional partners to support commercial operations.
• Support key regulatory and quality activities, including process performance qualification, continued process verification, deviations, change control, and process validation documentation.
• Stay current with evolving industry, scientific, and regulatory trends and contribute to the review and authorship of relevant sections of global regulatory filings.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The dedicated professional we seek is a great problem solver with these qualifications.

Basic Qualifications

• High school diploma / GED and 8 years of Engineering or Operations experience OR
• Associate's degree and 6 years of Engineering or Operations experience OR
• Bachelor's degree and 2 years of Engineering or Operations experience OR
• Master's degree

Preferred Qualifications

• 2+ years of experience in a pharmaceutical or biopharmaceutical environment supporting cGMP-regulated operations, engineering, manufacturing, or quality systems.
• Strong communication, presentation, organization, collaboration, and leadership skills.
• Experience with systems and processes such as E , DeltaV, deviations, CAPA, and change control.
• Technical understanding…