Manufacturing System Engineer - Testing Machine System Owner

BioSpace; New Albany (OH); On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive benefits

Flexible work model

Job summary

Amgen in New Albany, Ohio, is seeking a Manufacturing System Engineer - Testing Machine System Owner. This role owns automation for quality-critical testing equipment, designs control strategies, configures PLCs and HMIs, and maintains validation documentation in a regulated FDA/GMP environment.

Based on an Admin shift 8am–5pm, M-F, you will lead lifecycle activities, drive data-driven improvements, and collaborate with Quality, Regulatory Affairs, maintenance and operations to ensure safety and

Qualifications

• Masters or equivalent with automation experience in pharma/biotech preferred.
• Minimum education options reflect regulatory industry standards.
• Strong automation and data integrity knowledge required.

Responsibilities

• Own automation systems for testing equipment in a regulated environment.
• Design and implement control strategies and validation documentation.
• Lead lifecycle activities and data-driven performance improvements.

Skills

Automation experience

Communication skills

Project management

Problem-solving

Data analysis

Lean thinking

Education

Masters degree

Bachelors degree

Associate degree

High school diploma

Tools

Siemens

Rockwell

PLC programming

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll 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

Lets do this. Lets 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 Amgens 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

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

Key Responsibilities:

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.
• 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

• Masters degree
• Or
• Bachelors degree and 2 years of Automation experience in Pharmaceutical, Medical Devices, or Biotechnology industries
• Or
• Associates 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, well 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 where possible. Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

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.