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

Amgen • New Albany, OH

6d • $148,715 - $201,203

About The Position

The Senior Manager of Engineering provides 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. The role calls for deep expertise in pharmaceutical manufacturing and packaging technologies, as well as experience delivering complex automation and equipment projects in highly regulated environments.

The Senior Manager leads cross-functional engineering initiatives from concept development and technology selection through design, equipment development, integration, qualification, operational readiness, and ongoing manufacturing support. The role partners with Manufacturing/Operations, Quality, Automation, Validation, Maintenance, Supply Chain, Process Development, Regulatory, and external equipment suppliers to deliver robust, compliant, reliable, and scalable manufacturing solutions. The position combines technical detail with strategic program leadership, including management of risks, stakeholder influence, and resolution of complex issues.

The role also leads and develops engineers and technical professionals, builds organizational capabilities in equipment design, automation, packaging technologies, technical problem solving, and project execution, and establishes expectations that support technical rigor, collaboration, innovation, accountability, and continuous improvement.

Requirements

• A qualifying combination of education and relevant technical experience: doctorate plus 2 years; master’s degree plus 6 years; bachelor’s degree plus 8 years; associate’s degree plus 10 years; or high school diploma/GED plus 12 years. Experience must be in Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline.
• At least 2 years of experience directly managing people and/or leadership experience leading teams, projects, or programs, or directing allocation of resources. This experience may be concurrent with the required technical experience.
• Demonstrated experience with technologies associated with pharmaceutical combination-product/device assembly and packaging, including several relevant technologies such as automated or semi-automated medical device assembly, cartoning and case packing, component feeding and handling, labeling and verification, serialization and track-and-trace, vision and inspection, printing/coding/marking, leaflet feeding, robotics, conveyance, packaging automation, PLC/HMI systems, or equipment data acquisition and manufacturing-system interfaces.
• Significant engineering experience in pharmaceutical, biotechnology, medical device, combination-product, or another highly regulated manufacturing industry.
• Demonstrated experience leading the design, development, implementation, commissioning, and qualification of automated process equipment.
• Demonstrated leadership of complex, high-visibility capital or equipment projects involving multiple cross-functional organizations.
• Experience working directly with equipment OEMs, automation suppliers, system integrators, and engineering partners.
• Working knowledge of regulated manufacturing environments and applicable GMP/GxP principles.
• Ability to lead technical investigations and resolve complex equipment and manufacturing problems.
• Strong technical communication, leadership, stakeholder-management, and decision-making skills.

Nice To Haves

• Bachelor’s degree in Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline.
• Experience with secondary and tertiary packaging, labeling, and/or automated device assembly equipment.

Responsibilities

• Provide technical leadership for device assembly, labeling, secondary packaging, and tertiary packaging equipment and automation systems.
• Lead assessment, selection, design, development, implementation, and lifecycle management of process technologies and equipment.
• Develop equipment and automation strategies that support reliability, product quality, operational efficiency, flexibility, and technology standardization.
• Provide technical direction through concept development, design reviews, detailed engineering, equipment build and testing, installation, commissioning, qualification, and operational ramp-up.
• Review equipment architecture, automation concepts, control strategies, material flow, product handling, inspection systems, and machine interfaces.
• Identify technical risks early, develop mitigation strategies, and lead structured problem solving and root-cause analysis for equipment, automation, process, and reliability issues.
• Establish and promote engineering standards and best practices for equipment design, technology selection, maintainability, reliability, and lifecycle management.
• Lead complex capital and equipment projects involving multiple functions, suppliers, technologies, and manufacturing stakeholders.
• Translate product, process, business, and regulatory requirements into equipment and engineering requirements.
• Lead equipment projects through concept development, user requirements, specification, supplier selection, design reviews, FAT, SAT, commissioning, qualification, and production readiness.
• Own technical project execution and manage scope, schedule, technical risk, interfaces, dependencies, and critical decisions.
• Communicate project status, risks, tradeoffs, and recommendations to senior leadership, and document technical decisions with appropriate engineering rationale and risk assessment.
• Partner with Operations, Quality, Validation, Automation, Maintenance, Process Development, Supply Chain, Regulatory, and engineering organizations to deliver manufacturing capabilities.
• Facilitate technical discussions, align stakeholders when requirements or priorities conflict, and support sustainable transition of technologies into routine production.
• Communicate complex engineering topics to technical teams and executive leadership, and influence stakeholders without relying solely on direct authority.
• Lead technical relationships with equipment OEMs, system integrators, automation suppliers, and engineering partners.
• Set supplier expectations for specifications, deliverables, design reviews, and acceptance; constructively challenge suppliers to meet technical, quality, reliability, schedule, and operational requirements.
• Lead technical reviews and equipment milestones, including design reviews, FATs, SATs, and performance evaluations.
• Evaluate emerging equipment and automation technologies for current and future manufacturing needs.
• Lead, develop, coach, and mentor engineers and technical professionals.
• Build engineering capability in equipment design, automation, packaging technologies, technical problem solving, and project execution.
• Set clear expectations and accountability while encouraging technical rigor, collaboration, innovation, and continuous improvement.
• Develop internal technical expertise and effectively leverage external OEM and engineering resources.

Benefits

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• Discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements where possible.
• Career development opportunities.
• Health and welfare plans for staff and eligible dependents.
• Financial plans with opportunities to save toward retirement or other goals.
• Work/life balance support.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: No Education Listed