Manufacturing System Engineer - Testing Machine System Owner

Career Category Engineering 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 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. Manufacturing System Engineer - Testing Machine System Owner What you will do Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps drive scientific innovation and problem-solving, leading to better solutions that benefit both patients and society. Based in New Albany, Ohio, the site of Amgen’s new advanced product assembly and packaging plant, this role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects. The work schedule for this role will be an Admin shift, 8am-5pm, M-F Let’s do this. Let’s change the world. In this role, the Mfg. Systems (Automation) Engineer will:

Automation System Ownership and Development Serve as the Automation System Owner for quality-critical testing equipment, ensuring systems operate reliably, efficiently, and in full compliance with regulatory requirements. Design, develop, and maintain automation and control strategies that support accurate, compliant, and consistent test operations. Implement, configure, and optimize PLCs, HMIs, and other automation components to support system performance and data integrity. Maintain comprehensive documentation, including system design specifications, configuration records, and validation documentation. 2. Integration, Optimization, and Data Analysis Lead the integration of new automation technologies and instruments into the testing environment, ensuring seamless connectivity and data flow. Analyze system and test performance data to identify trends, enhance reliability, and drive continuous improvement initiatives. Conduct feasibility studies and cost-benefit analyses for automation improvements and upgrades that enhance quality and efficiency. 3. Troubleshooting and Lifecycle Support Provide expert-level technical support for automation-related issues, coordinating with maintenance, engineering, and quality teams to ensure minimal downtime. Manage system lifecycle activities, including upgrades, patching, and preventive maintenance, to maintain validated system states and ensure long-term reliability. Lead root cause analysis and corrective actions related to automation system performance or deviations. 4. Compliance and Quality Assurance Ensure all automation systems align with FDA, GMP, and internal Amgen quality standards. Partner closely with Quality and Regulatory Affairs to prepare for and support inspections, audits, and system-related regulatory submissions. Serve as the primary automation