Senior Engineer

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. 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. Senior Engineer What you will do Let’s do this. Let’s change the world. In this vital role you will lead the design, optimization, and reliability of systems and equipment that power the delivery of high-quality, life-changing therapies. Specific responsibilities include but are not limited to: Serve as the system owner for assigned utilities, ensuring compliance with cGMP and regulatory standards. Monitor system performance daily and ensure operational reliability and environmental requirements are met. Own the lifecycle management of assigned systems, supporting preventive and predictive maintenance strategies. Ensure maintenance job plans and documentation are follows site standards and regulatory expectations. Evaluate systems and assess impact during outages or deviations, providing timely technical support and documentation. Participate in project meetings, offering technical expertise for design reviews and system modifications. Author and maintain user requirement specifications and system documentation. Identify and implement design or operational improvements to enhance efficiency and reliability. Incorporate industry best practices and regulatory updates into system design and operations. Lead root cause analysis for major deviations or failures, driving resolution with multi-functional teams. Analyze performance data to identify trends, anomalies, and opportunities for improvement. Translate technical insights into clear, actionable updates for non-technical collaborators. Collaborate with internal customers to understand needs and align engineering solutions accordingly. Share knowledge and best practices across teams and sites to promote consistency, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Senior Engineer professional we seek is an individual with these qualifications.

Doctorate degree in Engineering Or Master’s degree in Engineering and 2 years of Engineering and/or Mfg Support experience Or Bachelor’s degree in Engineering and 4 years of Engineering and/or Mfg Support experience Preferred Qualifications: Working knowledge of pharmaceutical and biotechnology processes. Specialized expertise in industrial utilities, specifically in Reverse Osmosis, Water for Injection, and clean steam systems. Experience with utilities monitoring systems, including Building Management System (BMS), Process Control System (PCS), and PI data historian. Familiarity with Quality Management Systems (QMS), including validation, deviations, and CAPA management. Strong skills in problem solving, negotiation, persuasion, collaboration, project cost development, conflict resolution, leadership, team building, and schedule/resource planning. Effective verbal and written communication skills; proficiency in both Spanish and English. Flexibility to work extended shifts and/or weekends as required by business needs. What you