B23 Manufacturing Specialist

Career Category Manufacturing 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, 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. Specialist Manufacturing What You Will Do Let’s do this. Let’s change the world. In this vital role, the Manufacturing Specialist, Level 5. Will provide technical and process expertise to support deviation investigations, structured root cause analyses, and the development of practical, effective, and sustainable CAPAs. Partner with Manufacturing, Quality, Engineering, Process Development, and other cross-functional teams to evaluate events, analyze process data and supporting evidence, identify true root causes, and strengthen investigation conclusions and documentation. Assess proposed CAPAs for feasibility, effectiveness, compliance alignment, implementation risk, and potential unintended process impacts. Support manufacturing execution, troubleshooting, operational risk assessment, new product introductions, and the implementation of new systems, equipment, processes, and technologies. Drive continuous improvement based in, right-first-time execution, safety, compliance, process reliability, operational efficiency, and overall manufacturing performance. This position requires flexibility to support all manufacturing areas and schedules as dictated by production needs, including days, swings, graves, weekends, holidays, 5x8, 4x10, and 3 or 4x12-hour schedules.

Provide technical and process expertise to support deviation investigations, root cause analyses, and corrective and preventive action development. Partner with investigation owners, Manufacturing, Quality, Engineering, Process Development, and other cross-functional teams to evaluate events and determine appropriate investigation strategies. Apply strong process knowledge and critical thinking to assess available evidence, identify potential failure modes, evaluate competing hypotheses, and distinguish contributing factors from the true root cause. Facilitate and support structured root cause analysis activities using appropriate investigation tools and methodologies. Help develop CAPAs that directly address the identified root cause, are practical for the manufacturing environment, and can be effectively implemented and sustained. Evaluate proposed CAPAs for feasibility, effectiveness, unintended process impacts, and alignment with quality and compliance requirements. Support the collection, review, and interpretation of process data, batch documentation, equipment information, historical trends, and subject-matter expert input. Identify gaps in investigation logic, supporting evidence, or technical rationale and work with investigation teams to strengthen conclusions and documentation. Support and drive continuous improvement projects that improve safety, quality, compliance, process reliability, operational efficiency, and manufacturing performance. Partner with the Manufacturing Execution