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

Amgen

New Albany, OHOnsitePosted 1 day ago$148,715.15 - $201,202.85
Full TimeSenior LevelManufacturing & CMCPharmaceutical
Original posting ↗

Summary

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.

Job description

Engineering & Technical Leadership

  • 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.
  • 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 Expertise

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 Leadership

  • 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 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 Leadership

  • Partner 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 Management

  • Provide 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 Capability

  • Lead, 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.

Requirements

  • Doctorate degree and 2 years of engineering experience OR Master's degree and 6 years of engineering experience OR Bachelor's degree and 8 years of engineering experience OR Associate's degree and 10 years of engineering experience OR High school diploma/GED and 12 years of engineering experience
  • Minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources
  • Degree in Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline
  • Significant engineering experience within the pharmaceutical, biotechnology, medical device, combination-product, or other highly regulated manufacturing industry
  • Demonstrated experience with secondary and tertiary packaging, labeling, and/or automated device assembly equipment
  • Strong 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
  • Demonstrated ability to lead technical investigations and resolve complex equipment and manufacturing problems
  • Strong technical communication, leadership, stakeholder-management, and decision-making skills

Benefits

  • Retirement & Savings Plan
  • Medical, Dental & Vision
  • Life & Disability Insurance
  • Flexible Spending Accounts
  • Annual Bonus Program
  • Stock-Based Long-Term Incentives
  • Time-Off Plans
  • Flexible Work Models

Company overview

Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.

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