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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. 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.
Job Responsibility:
Design, develop, implement, and sustain automation, control, and mechanical systems supporting packaging and manufacturing operations
Serve as System Owner for assigned equipment and systems, accountable for system performance, reliability, lifecycle management, and regulatory compliance
Apply established engineering principles and Amgen standards to system design, configuration, modification, and continuous improvement activities
Develop, review, and approve system documentation including URS, specifications, design documents, SOPs, and lifecycle records
Provide technical requirements and direction to vendors, service providers, and internal partners
Integrate new automation technologies into existing manufacturing and packaging systems
Support process characterization, optimization, and performance monitoring to improve throughput, quality, and operational efficiency
Act as a technical authority (SME) for assigned systems, supporting routine operations and issue resolution
Conduct feasibility assessments, risk evaluations, and cost-benefit analyses for system enhancements
Provide advanced trouble shooting and problem-solving support for automation systems and equipment
Collaborate with Maintenance, Automation Technicians, Manufacturing, IS, and Quality to resolve issues and minimize downtime
Lead root cause investigations and support development and implementation of corrective and preventive actions
Plan and execute system upgrades, obsolescence mitigation, and reliability improvements
Ensure systems operate in compliance with GMP, GAMP, data integrity, and regulatory requirements
Support validation lifecycle activities including protocol development, execution, and reporting (IQ, OQ, PQ)
Maintain validated state of assigned systems and support regulatory inspections and audits
Partner with Quality, Validation, and Regulatory Affairs to address compliance-related issues
Lead or support automation-related capital and expense projects in alignment with site and network priorities
Coordinate with project managers, vendors, and engineering firms to deliver solutions within defined scope, schedule, and budget
Develop technical assessments, cost estimates, schedules, and project documentation
Communicate project status, risks, and performance metrics to stakeholders
Reverse engineer equipment and parts
Provide technical guidance, coaching, and knowledge transfer to operations and maintenance personnel
Develop and deliver training materials to support effective operation and maintenance of systems
Support commercial packaging operations by providing timely technical support and driving continuous improvement initiatives
Demonstrate Amgen leadership behaviors through collaboration, accountability, and continuous learning
Lead and execute reverse engineering activities including dimensional analysis, material identification, functional assessment, and design recreation using CAD, 3-D scanning technologies, and engineering analysis tools
Develop, review, and approve engineering models, drawings, and specifications for reverse-engineered parts in accordance with Amgen engineering standards and GMP requirements
Maintain reliability of additive manufacturing (3-D printing) for spare parts, fixtures, tooling, and non-product contact components, including risk, material compatibility, mechanical performance, and regulatory impact
Establish and maintain documentation required to support 3-D printed parts, including design records, material certifications, inspection results, and traceability documentation
Develop lifecycle strategies for digitally stored spare parts (digital inventory), including version control, cybersecurity considerations, and long-term accessibility
Provide technical guidance and training to Engineering, Maintenance, and Operations teams on reverse engineering methods, 3-D scanning technologies, and additive manufacturing standard methodologies
Own the end-to-end 3-D printing process for approved use cases, including: Functional equivalency
Technology and material selection
Printer and scanner qualification and maintenance
Print parameter definition and optimization
Post-processing, inspection, and acceptance criteria
Requirements:
Master’s degree
Bachelor’s degree and 2 years of relevant Automation, Packaging, or Manufacturing experience
Associate’s degree and 4 years of relevant Automation, Packaging, or Manufacturing experience
High school diploma / GED and 8 years of relevant Automation, Packaging, or Manufacturing experience
Nice to have:
Advanced degree in Engineering (Mechatronics, Electrical, Computer, Mechanical, or Chemical)
Experience in pharmaceutical or biotechnology manufacturing environments
Demonstrated System Owner or technical system lead experience
Knowledge of PLC/HMI programming and industrial automation platforms (e.g., Rockwell, Siemens)
CSWA certification for SolidWorks. Inventor and Fusion 360 proficiency
Understanding of validation, documentation, and change management in regulated environments
Strong analytical, problem-solving, communication, and collaboration skills
Familiarity with Operational Excellence and Lean principles
What we offer:
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