Mfg Systems Engineer - System Owner

Amgen • New Albany, OH

1d

About The Position

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. System Owner Manufacturing Systems Engineer What you will do Let’s do this. Let’s change the world. At Amgen, we are committed to advancing science through continuous learning, innovation, and inclusion. In this role, you’ll apply advanced engineering principles to design, implement, and optimize complex automation systems supporting our innovative assembly and packaging operations. You will be part of a diverse, dynamic team responsible for developing automation strategies that ensure safety, quality, and efficiency across multiple packaging lines and systems.

Requirements

• Master’s degree Or Bachelor’s degree and 2 years of relevant Automation, Packaging, or Manufacturing experience Or Associate’s degree and 4 years of relevant Automation, Packaging, or Manufacturing experience Or High school diploma / GED and 8 years of relevant Automation, Packaging, or Manufacturing experience

Nice To Haves

• 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.

Responsibilities

• 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

Benefits

• 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 where possible.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees