Engineer System Owner - Packaging

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 broad and deep pipeline and portfolio 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. Engineer System Owner - Packaging What you will do Let’s do this. Let’s change the world. In this vital role you will apply engineering expertise to optimize complex systems and processes, develop and maintain technical documentation and drive operational excellence through data-driven decision-making and continuous improvement. Specific responsibilities include but are not limited to: Support or Lead on Deviations, CAPAs, Technical Assessments, Change Controls, Periodic Reviews and Internal/External Audits  Lead and execute corrective and preventive actions to enhance engineering controls on the manufacturing processes. Including the Effectiveness Verification of actions  Develop maintenance strategies and controls to improve and maintain equipment reliability by monitoring key performance indicators and metrics. Conduct root cause analysis and document findings  Develop and execute equipment testing protocols and analyze data to support investigations  Review and update documentation such as validation protocols, design documents, SOPs, and data integrity assessments  Collaborate with peers to ensure quality and compliance of documents. Review and revise documents including data integrity and security assessments, validation protocols and reports, design documents and SOPs.  Create and refine engineering  technical supporting documentation and procedures impacting multiple departments or systems.  Apply engineering principles and advanced techniques to develop creative technical solutions  Manage equipment lifecycle and maintenance using Maximo (create, execute, and approve work orders)  Work with cross-functional teams (e.g., QA, Validation, Facilities) to define system/facility modifications  Partner with project managers to ensure projects meet scope, schedule, and quality goals  Coordinate work with external consultants, engineers, and vendors  Engage with vendors to troubleshoot equipment issues and implement improvements  Model a culture of accountability, safety, and continuous learning in alignment with Amgen values. Proficiency in computer applications such as Word, Excel, PowerPoint, and or data visualization tools. Strong organizational skills with the ability to manage priorities, document work clearly, and meet project timelines. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual contributor with these qualifications.

Master’s degree in Engineering OR Bachelor’s degree in Engineering and 2 years of Engineering experience Preferred Qualifications: Experience working in a GMP-regulated environment within the pharmaceutical, medical device, or biotechnology industry Proficiency in technical report