Manufacturing System Engineer - Testing Machine System Owner

Amgen; New Albany (OH); On-site; USD 110,000 - 160,000; Full time

Job summary

Amgen is seeking a Manufacturing System Engineer to own testing machine automation. You will design and maintain automation strategies, configure PLCs/HMI, and ensure data integrity for validated testing environments. You will lead integrations, analyze performance data, and support audits with Quality and Regulatory teams.

The role emphasizes lifecycle management, documentation, and collaboration across maintenance, engineering, and operations within a GMP setting.

Qualifications

• Master’s degree or equivalent in a relevant engineering field.
• Bachelor’s degree with 2+ years automation experience in pharma/biotech, or equivalent combos.
• Experience with automation systems in regulated environments and data integrity.
• Strong troubleshooting and cross-functional collaboration skills.

Responsibilities

• Serve as Automation System Owner for testing equipment and ensure regulatory compliance.
• Design and maintain automation strategies for accurate test operations.
• Configure PLCs, HMIs, and automation components for performance and data integrity.
• Maintain documentation, validation records, and lifecycle management.
• Lead integration of new automation technologies and data analysis.
• Provide expert technical support and coordinate with maintenance, engineering, and quality teams.

Skills

Automation experience

Regulatory compliance

Data analysis

Troubleshooting

Communication skills

Education

Master’s degree

Bachelor’s degree + 2 years automation experience

Associate’s degree + 6 years automation experience

High school diploma/GED + 8 years automation experience

Tools

Siemens

Rockwell

Machine Vision

Serialization

Robotics

Job description

Manufacturing System Engineer - Testing Machine System Owner

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.

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.

Key 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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.

What We Expect Of You

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

Basic Qualifications

• Master’s degree
• Or
• Bachelor’s degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
• Or
• Associate’s degree and 6 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
• Or
• High school diploma/GED and 8 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries

Preferred Qualifications

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

What You Can Expect Of Us

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.

Sponsorship

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.

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.

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 where possible. Refer to the Work Location Type in the job posting to see if this applies.