Engineer I

Job description

Career CategoryEngineeringJob DescriptionJoin Amgen’s Mission of Serving PatientsAt 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. Engineer I What you will doLet’s do this. Let’s change the world. In this vital role you will technically support manufacturing processes, secondary packaging operations, automated inspection systems, labeling technologies, and business applications while ensuring assigned systems remain qualified, compliant, and inspection ready throughout their lifecycle. The Engineer I serves as the System Owner for assigned assets and computerized systems, supporting engineering activities related to system reliability, lifecycle management, validation, change control, and operational excellence. The position collaborates closely with Quality, Manufacturing, Automation, Maintenance, Supply Chain, Information Systems, and Project teams to execute engineering activities in accordance with applicable regulatory requirements, corporate standards, and business objectives. System Ownership Serve as the System Owner for assigned manufacturing systems, computerized systems, packaging equipment, facility assets, utilities, and infrastructure. Maintain assigned systems in a qualified, compliant, reliable, and inspection-ready state throughout their lifecycle. Develop, maintain, and update engineering documentation including specifications, engineering assessments, lifecycle documentation, and technical reports. Review and support preventive maintenance strategies, calibration programs, engineering changes, and system improvements. Monitor system performance and implement reliability, operational excellence, and continuous improvement initiatives. Maintain computerized systems in compliance with applicable regulatory requirements, including vulnerability assessments and system lifecycle documentation. Support deployment and lifecycle activities for manufacturing technology projects, including operating system upgrades, endpoint management migrations, and infrastructure modernization initiatives. Provide technical ownership of SAP-integrated operational systems supporting shipping interfaces, label printing, scale connectivity, report tracking and automated packaging workflows. Manage business applications by supporting incident resolution, problem management, troubleshooting, and continuous system improvements. Manufacturing and Packaging Support Support manufacturing operations, secondary packaging processes, and shipping systems. Provide engineering support for labeling systems, barcode technologies, automated vision inspection systems, printers, scanners, and packaging automation. Troubleshoot technical issues affecting manufacturing and packaging operations while implementing sustainable engineering solutions. Support manufacturing process improvements that enhance equipment reliability, operational efficiency, and product quality. Quality and Compliance Perform technical investigations and root cause analyses using structured problem-solving methodologies. Support Change Control activities by performing engineering impact assessments, risk evaluations, and qualification assessments. Ensure engineering activities comply with GMP regulations, corporate engineering standards, and applicable regulatory requirements. Maintain documentation in accordance with Good Documentation Practices (GDP) and quality system expectations. Project Support Support capital projects, equipment upgrades, infrastructure improvements, and manufacturing system enhancements. Participate in project planning, design reviews, commissioning, Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), qualification, startup, and project turnover. Author, review, and execute validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, engineering rationale documents, and validation summary reports. Review engineering designs and contractor deliverables to ensure compliance with regulatory, engineering, and business requirements. Coordinate validation and implementation activities with Engineering, Quality Assurance, Manufacturing, Automation, Supply Chain, and external contractors. Support project execution to achieve scope, schedule, budget, and quality objectives. Support implementation of SAP-integrated operational workflows and business process improvements. Audits and Inspection Readiness Support internal audits, customer audits, and regulatory inspections as the engineering subject matter expert for assigned systems. Present engineering documentation, validation packages, technical assessments, and qualification strategies during inspections. Support responses to audit observations and engineering-related quality actions. Maintain assigned systems and engineering documentation in a continuous state of inspection readiness. Cross-Functional Collaboration Partner with Quality, Manufacturing, Automation, Maintenance, Validation, Supply Chain, EHSS, and Information Systems to support site objectives. Collaborate with global engineering and technology teams during lifecycle projects and system deployments. Promote continuous improvement, operational excellence, and engineering best practices. Share technical knowledge and support the development of engineering solutions across functional teams. What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is a dynamic with these qualifications. Basic Qualifications: Master’s degree OR Bachelor’s degree and 2 years of Engineering experience OR Associate’s degree and 4 years of Engineering experience OR High school diploma / GED and 6 years of Engineering experience Preferred Qualifications: Experience supporting GMP manufacturing or pharmaceutical operations. Knowledge of equipment lifecycle management and System Ownership principles. Understanding of GMP, data integrity, computerized system validation, and change control processes. Experience supporting manufacturing automation, packaging equipment, or industrial control systems. Experience participating in commissioning, qualification, and validation activities. Strong troubleshooting, analytical, and problem-solving skills. Excellent written and verbal communication skills with the ability to work effectively across cross-functional teams. Technical Skills Experience or familiarity with: SAP ERP ServiceNow Microsoft Windows Operating Systems (Windows 10/11) Zebra printers Domino printers Industrial barcode scanners Label printing systems Automated vision inspection systems Packaging automation equipment Manufacturing IT infrastructure Computerized System Validation (CSV) GMP documentation practices Core Competencies Technical problem solving System ownership and accountability Continuous improvement mindset Cross-functional collaboration Customer focus Attention to detail Regulatory compliance Project execution Communication and technical documentation