Mfg Systems Engineer System Owner

Career Category

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. 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.

System Owner Manufacturing Systems Engineer

What you will do

Lets do this. Lets change the world. At Amgen we are committed to advancing science through continuous learning innovation and this role youll 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.

Key Responsibilities

System Design Ownership and Development

• 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.

Integration Optimization and Operations Engineering

• 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.

Troubleshooting and Technical Support

• 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.

Compliance Validation and Quality Assurance

• 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.

Project Management and Design Engineering

• 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

Training Leadership and Production Support

• 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.

Advanced Manufacturing Reverse Engineering and Additive Manufacturing (3-D Scanning and Printing)

• 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

What we expect of you

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

Basic Qualifications:

Masters degree

Or

Bachelors degree and 2 years of relevant Automation Packaging or Manufacturing experience

Or

Associates 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

Preferred Qualifications:

• 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 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.

Apply now and make a lasting impact with the Amgen team.

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.

Salary Range