Sr. Manager of Engineering (Device Assembly, Labeling & Packaging)

Job description

Career CategoryEngineeringJob DescriptionJoin 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. What you will do Let’s do this. Let’s change the world. In this role the Senior Manager of Engineering is responsible for providing technical and engineering leadership for the design, development, implementation, qualification, and lifecycle management of pharmaceutical device assembly, labeling, and secondary and tertiary packaging process equipment. This role requires deep technical expertise in pharmaceutical manufacturing and packaging technologies, combined with demonstrated industry experience delivering complex automation and equipment projects in a highly regulated environment. The Senior Manager will lead high-visibility, cross-functional engineering initiatives from early concept and technology selection through design, equipment development, integration, qualification, operational readiness, and sustained manufacturing support. The successful candidate will work closely with Manufacturing/Operations, Quality, Automation, Validation, Maintenance, Supply Chain, Process Development, Regulatory, and external equipment suppliers to deliver robust, reliable, compliant, and scalable manufacturing solutions. The position requires a leader who can operate effectively at both the technical detail and strategic program level, challenge equipment designs and technical decisions, manage complex project risks, influence stakeholders, and drive issues to resolution. Key ResponsibilitiesEngineering & Technical LeadershipProvide technical leadership for device assembly, labeling, secondary packaging, and tertiary packaging equipment and automation systems. Lead the assessment, selection, design, development, implementation, and lifecycle management of process technologies and equipment. Develop equipment and automation strategies that support manufacturing reliability, product quality, operational efficiency, flexibility, and long-term technology standardization. Provide technical direction through equipment concept development, design reviews, detailed engineering, equipment build, testing, installation, commissioning, qualification, and operational ramp-up. Critically review equipment architecture, automation concepts, control strategies, material flow, product handling, inspection systems, and machine interfaces. Apply strong engineering fundamentals and industry knowledge to identify technical risks early and develop effective mitigation strategies. Drive technical problem solving and structured root-cause analysis for complex equipment, automation, process, and reliability issues. Establish and promote engineering standards and best practices for equipment design, technology selection, maintainability, reliability, and lifecycle management. Equipment & Technology ExpertiseThe successful candidate should have demonstrated experience with technologies associated with pharmaceutical combination-product/device assembly and packaging, including several of the following: Automated and semi-automated medical device assembly Cartoning and case packing Product and component feeding and handling systems Label application and verification Serialization and track-and-trace technologies Vision and inspection systems Printing, coding, and marking systems Leaflet and booklet feeding Robotics and material handling Conveyance and product-transfer systems Secondary and tertiary packaging automation PLC/HMI and industrial automation systems Equipment data acquisition and manufacturing system interfaces Capital Project & Program LeadershipLead complex, high-visibility engineering and capital equipment projects involving multiple functions, suppliers, technologies, and manufacturing stakeholders. Translate product, process, business, and regulatory requirements into clear equipment and engineering requirements. Lead equipment projects through key phases including concept development, user requirements, specification, supplier selection, design reviews, FAT, SAT, commissioning, qualification, and production readiness. Own technical project execution while proactively managing scope, schedule, technical risk, interfaces, dependencies, and critical decisions. Establish clear escalation paths and communicate project status, technical risks, tradeoffs, and recommendations to senior leadership. Ensure technical decisions are documented and supported by appropriate engineering rationale and risk assessment. Cross-Functional LeadershipPartner closely with Operations, Quality, Validation, Automation, Maintenance, Process Development, Supply Chain, Regulatory, and other engineering organizations to successfully deliver new manufacturing capabilities. Facilitate technical discussions and drive alignment across functions when requirements or priorities conflict. Build strong partnerships with manufacturing teams to ensure new technologies are operationally sustainable and successfully transitioned into routine production. Influence stakeholders and senior leaders without relying solely on direct authority. Communicate complex engineering topics clearly to both highly technical teams and executive leadership. Supplier & OEM ManagementProvide technical leadership in relationships with equipment OEMs, system integrators, automation suppliers, and engineering partners. Establish clear technical expectations, specifications, deliverables, design-review criteria, and acceptance requirements. Challenge suppliers constructively to ensure equipment solutions meet technical, quality, reliability, schedule, and operational requirements. Lead technical reviews and critical equipment milestones including design reviews, FATs, SATs, and performance evaluations. Evaluate emerging equipment and automation technologies and assess their applicability to current and future manufacturing needs. People Leadership & Organizational CapabilityLead, develop, coach, and mentor engineers and technical professionals. Build engineering capability in equipment design, automation, packaging technologies, technical problem solving, and project execution. Establish clear expectations and accountability while creating an environment that encourages technical rigor, collaboration, innovation, and continuous improvement. Develop internal technical expertise while effectively leveraging external OEM and engineering resources. 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, inflamm