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

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.

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.

Automation Maintenance Technician

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.

Let’s do this. Let’s change the world. In this role the Associate Mfg Systems Engineer for the new Amgen Advanced Assembly and Final Product Operation facility will be part of the Facilities & Engineering team responsible for providing automation and technical support for the safe and reliable operation of our advanced automated warehouse and automated guided vehicle systems (Automated storage and retrieval System - ASRS). You will have the exciting opportunity to support performing advanced installation, troubleshooting, maintenance, repair, testing, and documentation/logs of our advanced warehouse automation systems that require strong analytical problem-solving techniques.

Specific Responsibilities include but are not limited to:

• →Strictly follow the company’s safety and cGMP policies and procedures.
• →Provide operational shift support for process control applications applying Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), Variable Frequency Drives (VFD) and vision systems.
• →Apply engineering principles of process automation to provide technical support to the automated warehouse, automated guided vehicles, and manufacturing production.
• →Implement control system troubleshooting support for the ASRS integrated system.
• →Implement automated process changes to improved equipment performance or upgraded equipment technologies.
• →Participate in technical root cause analysis, incident investigations, and troubleshooting on automation control issues related to electrical, instrumentation, and control systems.
• →Perform required work in a GMP regulated manufacturing setting.
• →Implement Preventative and Corrective maintenance.
• →Ensure strict adherence to Good Manufacturing Practices (GMP) and maintain accurate GMP documentation following ALCOA+ principles.
• →Support project management efforts for automation-related projects.
• →Handle Automation Systems lifecycle including controlled changes, software versioning, and control system qualification. Ensure all changes are properly documented and approved.
• →Support Data Integrity Assessments.
• →Maintain automated warehouse systems applying Allen Bradley Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
• →Support Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen’s goals.
• →Business Process Improvements including departmental Standard Operating Procedures (SOP) and Job plans for the area of responsibility to assure all maintenance operations are performed safely and reliably.

• 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.

The 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

• 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.

• 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.

• 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.

• 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.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Doctorate degree and 2 years of Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline experience

OR

Master’s degree and 6 years of Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline experience

OR

Bachelor’s degree and 8 years of Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline experience

OR

Associate’s degree and 10 years of Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline experience

OR

High school diploma / GED and 12 years of Mechanical Engineering, Electrical Engineering, Automation/Controls Engineering, Manufacturing Engineering, Chemical Engineering, Packaging Engineering, or a related technical discipline experience

In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

• Bachelor’s 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.

As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:

• A 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
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models, including remote and hybrid work arrangements, where possible

Objects in your future are closer than they appear. Join us.

Sponsorship for this role is not guaranteed.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.