Manufacturing System Engineer - Testing Machine System Owner

Amgen • New Albany, OH

1d • $105,363 - $142,549 • Onsite

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. 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.

Manufacturing System Engineer - Testing Machine System Owner

What you will do
Let’s do this. Let’s change the world. At Amgen, we are committed to being science-based and follow a continuous learning approach to advancing science, driving discovery, and igniting innovation that works to help reduce disease. It is in this context that we endorse an inclusive and diverse workforce that helps drive scientific innovation and problem-solving, leading to better solutions that benefit both patients and society.

Based in New Albany, Ohio, the site of Amgen’s new advanced product assembly and packaging plant, this role will apply advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, processes, and/or capital projects.

The work schedule for this role will be an Admin shift, 8am-5pm, M-F

Let’s do this. Let’s change the world. In this role, the Mfg. Systems (Automation) Engineer will:

Key Responsibilities:

1. Automation System Ownership and Development
Serve as the Automation System Owner for quality-critical testing equipment, ensuring systems operate reliably, efficiently, and in full compliance with regulatory requirements.
Design, develop, and maintain automation and control strategies that support accurate, compliant, and consistent test operations.
Implement, configure, and optimize PLCs, HMIs, and other automation components to support system performance and data integrity.
Maintain comprehensive documentation, including system design specifications, configuration records, and validation documentation.
2. Integration, Optimization, and Data Analysis
Lead the integration of new automation technologies and instruments into the testing environment, ensuring seamless connectivity and data flow.
Analyze system and test performance data to identify trends, enhance reliability, and drive continuous improvement initiatives.
Conduct feasibility studies and cost-benefit analyses for automation improvements and upgrades that enhance quality and efficiency.
3. Troubleshooting and Lifecycle Support
Provide expert-level technical support for automation-related issues, coordinating with maintenance, engineering, and quality teams to ensure minimal downtime.
Manage system lifecycle activities, including upgrades, patching, and preventive maintenance, to maintain validated system states and ensure long-term reliability.
Lead root cause analysis and corrective actions related to automation system performance or deviations.
4. Compliance and Quality Assurance
Ensure all automation systems align with FDA, GMP, and internal Amgen quality standards.
Partner closely with Quality and Regulatory Affairs to prepare for and support inspections, audits, and system-related regulatory submissions.
Serve as the primary automation liaison during FDA and internal audits, providing clear communication and documentation regarding system design, data integrity, and validation.
5. Cross-Site Collaboration and Project Management
Collaborate with automation peers and system owners across the Amgen network to share standard methodologies, harmonize automation strategies, and align on global quality standards.
Lead or support automation-related projects from concept through implementation, ensuring deliverables meet safety, quality, and business objectives.
Track and communicate project progress, technical landmarks, and system performance metrics to partners.
6. Training and Technical Development
Develop and deliver training programs for engineering, maintenance, and operations staff on the use, troubleshooting, and maintenance of automated testing systems.
Create and maintain training documentation to ensure technical competency and system compliance.
Mentor team members and foster a culture of technical excellence and continuous learning in automation technologies.
This position is a key role within the Engineering and Maintenance department, responsible for the ownership, compliance, and continuous improvement of automation systems supporting quality-critical testing. The successful candidate will apply deep technical expertise across multiple engineering disciplines—spanning process control, instrumentation, equipment reliability, and data integrity—to ensure systems perform to Amgen’s highest standards of quality and compliance.

Production Support
The Automation System Owner will collaborate with engineering, maintenance, and quality teams to support day-to-day operations of testing and packaging systems. Responsibilities include driving data-informed performance improvements, implementing system enhancements, and ensuring robust communication across the Amgen site network to sustain and elevate technical and operational excellence.

Requirements

• Master’s degree
• Bachelor’s degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
• Associate’s degree and 6 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
• High school diploma/GED and 8 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
• Knowledge and/or experience of pharmaceutical/biotech processes, especially in the area of final drug product operations
• Knowledge in Data Integrity and Security
• Extensive understanding and background in programming, design, installation, validation, and lifecycle management of manufacturing process controls, automation, field instrumentation technologies
• Ability to interpret and apply GAMPs and GMPs and familiarity with documentation in a highly regulated environment
• Comprehensive understanding of validation protocol execution requirements as well as knowledge of validation processes and requirements as applied to new equipment installations
• Organizational, project management, problem-solving, as well as validation protocol, and technical writing capability
• Excellent communication (verbal/written) and presentation skills
• Demonstrated interpersonal skills, including: collaboration, influencing, and facilitation
• Understanding of Operational Excellence and Lean Transformation in the Automation and Engineering Context

Nice To Haves

• Advanced degree in Mechatronics, Computer, Electrical, Mechanical, or Chemical Engineering
• Exposure to Machine Vision, Serialization, Robotics, Siemens, and Rockwell software platform

Responsibilities

• Serve as the Automation System Owner for quality-critical testing equipment, ensuring systems operate reliably, efficiently, and in full compliance with regulatory requirements.
• Design, develop, and maintain automation and control strategies that support accurate, compliant, and consistent test operations.
• Implement, configure, and optimize PLCs, HMIs, and other automation components to support system performance and data integrity.
• Maintain comprehensive documentation, including system design specifications, configuration records, and validation documentation.
• Lead the integration of new automation technologies and instruments into the testing environment, ensuring seamless connectivity and data flow.
• Analyze system and test performance data to identify trends, enhance reliability, and drive continuous improvement initiatives.
• Conduct feasibility studies and cost-benefit analyses for automation improvements and upgrades that enhance quality and efficiency.
• Provide expert-level technical support for automation-related issues, coordinating with maintenance, engineering, and quality teams to ensure minimal downtime.
• Manage system lifecycle activities, including upgrades, patching, and preventive maintenance, to maintain validated system states and ensure long-term reliability.
• Lead root cause analysis and corrective actions related to automation system performance or deviations.
• Ensure all automation systems align with FDA, GMP, and internal Amgen quality standards.
• Partner closely with Quality and Regulatory Affairs to prepare for and support inspections, audits, and system-related regulatory submissions.
• Serve as the primary automation liaison during FDA and internal audits, providing clear communication and documentation regarding system design, data integrity, and validation.
• Collaborate with automation peers and system owners across the Amgen network to share standard methodologies, harmonize automation strategies, and align on global quality standards.
• Lead or support automation-related projects from concept through implementation, ensuring deliverables meet safety, quality, and business objectives.
• Track and communicate project progress, technical landmarks, and system performance metrics to partners.
• Develop and deliver training programs for engineering, maintenance, and operations staff on the use, troubleshooting, and maintenance of automated testing systems.
• Create and maintain training documentation to ensure technical competency and system compliance.
• Mentor team members and foster a culture of technical excellence and continuous learning in automation technologies.
• Collaborate with engineering, maintenance, and quality teams to support day-to-day operations of testing and packaging systems.
• Drive data-informed performance improvements, implement system enhancements, and ensure robust communication across the Amgen site network to sustain and elevate technical and operational excellence.

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: Senior