Engineer I

About the role

Join Amgen’s mission of serving patients at Amgen, where you can 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.

Responsibilities

• 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.
• Support deployment and lifecycle activities for manufacturing technology projects, including operating system upgrades, endpoint management migrations, and infrastructure modernization initiatives.
• Manage business applications by supporting incident resolution, problem management, troubleshooting, and continuous system improvements.
• 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.
• 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.
• Support project execution to achieve scope, schedule, budget, and quality objectives.
• Audits and Inspection Readiness Support internal audits, customer audits, and regulatory inspections as the engineering subject matter expert for assigned systems.
• 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.
• Share technical knowledge and support the development of engineering solutions across functional teams.

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
• 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
• Experience 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

Skills

• 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
• Learning agility