B23 Manufacturing Specialist

Job description

Career CategoryManufacturingJob DescriptionJoin 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. Key Responsibilities: 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 team to support operations as needed, including troubleshooting process issues, assessing operational risks, resolving execution barriers, and providing technical guidance during manufacturing activities. Support new product introductions and the implementation of new systems, equipment, processes, and technologies by providing process expertise, assessing operational readiness, and helping resolve implementation challenges. Provide recommendations to improve investigation quality, consistency, efficiency, and right-first-time documentation. Support investigation teams in preparing for discussions with internal auditors and regulatory inspectors by ensuring technical conclusions are clear, evidence-based, and defensible. Communicate complex technical and process-related topics clearly and effectively to technical and nontechnical audiences at all levels of the organization. Build effective relationships across functions and serve as a trusted technical partner to Manufacturing, Quality, Engineering, Process Development, and other support teams. Prepare and review clear, concise, compliant, and technically sound investigation documentation, assessments, recommendations, and supporting materials. What We Expect of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a proactive and collaborative problem-solver with strong process knowledge, sound technical judgment, and the ability to help cross-functional teams reach evidence-based, practical, and sustainable solutions. Basic Qualifications Doctorate degree OR Master’s degree and 2 years of manufacturing or operations experience OR Bachelor’s degree and 4 years of manufacturing or operations experience OR Associate’s degree and 8 years of manufacturing or operations experience OR High school diploma / GED and 10 years of Manufacturing or operations experience Preferred Qualifications Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline. Five or more years of experience in biotechnology or pharmaceutical manufacturing, process development, engineering, technical operations, or quality assurance within a cGMP-regulated environment. Three or more years of experience in a production Area Lead, Specialist, Manager, or comparable leadership role with responsibility for leading teams, projects, programs, or resource allocation. Strong knowledge of biotechnology manufacturing processes, equipment, batch documentation, quality systems, and technical elements associated with biological or chemical processing. Experience supporting complex deviation investigations, structured root cause analyses, and the development or evaluation of corrective and preventive actions. Working knowledge of investigation and root cause analysis methodologies, including fishbone analysis, fault-tree analysis, five whys, process mapping, barrier analysis, or similar tools. Demonstrated ability to analyze process data, batch records, equipment information, historical events, and technical documentation; evaluate competing hypotheses; and develop evidence-based conclusions. Ability to develop or assess CAPAs that address the identified root cause, meet quality and compliance requirements, and are practical for implementation within a manufacturing environment. Experience supporting manufacturing execution, continuous improvement initiatives, plant start-up activities, new product introductions, or the implementation of new systems, equipment, and technologies. Previous experience managing employees or demonstrated leadership experience in coaching, mentoring, team development, performance management, and conflict resolution. Strong analytical, problem-solving, project management, and organizational skills, with the ability to manage competing priorities and respond to time-sensitive operational needs. Excellent written, verbal, and technical communication skills, including the ability to produce clear documentation and com