Manufacturing Systems Engineer

Amgen SA; Juncos (PR); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Group medical, dental & vision

Stock-based long-term incentives

Time-off plans

Flexible work models

Job summary

Amgen is seeking a Manufacturing Systems Engineer to support manufacturing technology and automation systems, driving digital manufacturing initiatives and ensuring regulatory compliance. The role focuses on AML-14 standards, system validation, and cross-functional collaboration to enhance production performance.

The ideal candidate has a Bachelor's in engineering and at least 2 years of experience in manufacturing systems or automation, with familiarity in MES/SCADA, data integrity, and

Qualifications

• Bachelor's degree in engineering and 2 years of Manufacturing Systems/Automation experience.
• Experience with Manufacturing Execution Systems (MES) and SCADA platforms.
• Knowledge of cGMP, data integrity, and validation processes (CSV).

Responsibilities

• Serve as a subject matter expert in PLC Configuration, SCADA, and other manufacturing IT system technologies.
• Lead system implementation, configuration, and support activities across production environments for automation systems.
• Collaborate with multi-functional teams to define system requirements and ensure alignment with operational goals.
• Monitor system performance and identify opportunities for optimization and automation.

Skills

Manufacturing Systems/Automation

MES

SCADA

Regulatory compliance

Education

Bachelor's degree in engineering

Tools

MES

SCADA

Job description

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 lie within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

MANUFACTURING SYSTEMS ENGINEER

What you do

Let’s do this. Let’s change the world. In this vital role you will support manufacturing technology and automation systems, implementation, and optimization of digital manufacturing systems, enable data-driven operations and ensure compliance with regulatory and cybersecurity standards.

Specific responsibilities include but are not limited to:

• Serve as a subject matter expert in PLC Configuration, SCADA, and other manufacturing IT system technologies.
• Execute AML-14 Filling and Inspection automation standard work practices attained to automation workstream deliverables.
• Lead system implementation, configuration, and support activities across production environments for automation systems.
• Collaborate with multi-functional teams to define system requirements and ensure alignment with operational goals.
• Monitor system performance and seek opportunities for optimization and automation of manufacturing systems.
• Ensure system compliance with cGMP, data integrity, and cybersecurity requirements.
• Participate in system validation and change control processes, ensuring documentation accuracy.
• Analyze system data to support investigations, performance reviews, and strategic decision-making.
• Provide technical support and training to system users, promoting adoption and best practices.
• Stay informed on emerging technologies and digital trends in manufacturing systems.
• Contribute to SOP development and revisions related to system operations and compliance.
• Promote a culture of digital innovation, collaboration, and operational excellence.

What we expect from you

We are all different, yet we all use our unique contributions to serve patients. The Mfg. Systems Engineer professional we seek is a highly tech individual with these qualifications.

Basic Qualifications:

Bachelor’s degree in engineering and 2 years of Manufacturing Systems/Automation experience

Preferred Qualifications

• Experience with Manufacturing Execution Systems (MES) and SCADA platforms.
• Strong background in manufacturing IT systems, automation, and digital manufacturing technologies.
• Experience leading system implementation, configuration, integration, and support in a manufacturing environment.
• Knowledge of pharmaceutical, biotechnology, or regulated manufacturing operations.
• Understanding of cGMP regulations, data integrity requirements, and compliance standards.
• Experience with computer system validation (CSV) and change control processes.
• Knowledge of cybersecurity principles and their application within manufacturing systems.
• Ability to analyze and interpret manufacturing system data to drive operational improvements and support investigations.
• Experience with process optimization, automation initiatives, and continuous improvement projects.
• Problem Solving Skills and experience in troubleshooting techniques
• Strong project management skills, including managing timelines, stakeholders, and cross-functional teams.
• Experience collaborating with engineering, manufacturing, quality, validation, and IT teams.
• Ability to develop and revise Standard Operating Procedures (SOPs) and technical documentation.
• Experience providing technical support, user training, and system troubleshooting.
• Familiarity with Industry 4.0, digital transformation, and smart manufacturing technologies.
• Strong communication, problem-solving, and leadership skills.
• Experience in highly regulated environments such as biopharmaceutical, pharmaceutical, medical device, or GMP manufacturing facilities.

What you can expect from us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising 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 including:

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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 and an annual site shutdown
• 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 of 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 you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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.