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

Amgen•New Albany, OH

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 technical expertise in pharmaceutical manufacturing and packaging technologies, along with experience delivering complex automation and equipment projects in highly regulated environments. The position leads high-visibility, cross-functional engineering initiatives from concept development and technology selection through equipment design and development, integration, qualification, operational readiness, and ongoing manufacturing support. It partners 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 successful candidate operates at both technical-detail and strategic-program levels, challenges equipment designs and technical decisions, manages project risks, influences stakeholders, and drives issues to resolution. The role also leads and develops engineers and technical professionals, builds organizational engineering capabilities, and establishes expectations and accountability while fostering technical rigor, collaboration, innovation, and continuous improvement.

Responsibilities

Provide 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.
Review equipment architecture, automation concepts, control strategies, material flow, product handling, inspection systems, and machine interfaces.
Identify technical risks early and develop mitigation strategies; drive 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.
Lead complex, high-visibility engineering and capital 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, factory acceptance testing (FAT), site acceptance testing (SAT), commissioning, qualification, and production readiness.
Own technical project execution and proactively manage scope, schedule, technical risk, interfaces, dependencies, and critical decisions.
Communicate project status, technical risks, tradeoffs, and recommendations to senior leadership, and ensure technical decisions are documented with appropriate engineering rationale and risk assessment.
Partner with Operations, Quality, Validation, Automation, Maintenance, Process Development, Supply Chain, Regulatory, and other engineering organizations to deliver manufacturing capabilities.
Facilitate technical discussions, align functions when requirements or priorities conflict, and help transition new technologies into routine production.
Influence stakeholders and senior leaders without relying solely on direct authority; communicate complex engineering topics to technical teams and executive leadership.
Lead relationships with equipment OEMs, system integrators, automation suppliers, and engineering partners; establish technical expectations, specifications, deliverables, design-review criteria, and acceptance requirements.
Challenge supplier solutions to ensure they meet technical, quality, reliability, schedule, and operational requirements.
Lead supplier 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 fostering 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.

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