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Manufacturing Systems Engineer

Amgen

US - Puerto Rico - JuncosMidH-1B sponsor company
Sign in to applyVerified 2h ago
Location
US - Puerto Rico - Juncos
Work model
On-Site
Level
Mid
H-1B history
137 approvals (FY2023)
Posted
Sep 17, 2026

Skills

Cybersecurity

About this role

Career Category Engineering 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

Listing verified 2h ago. Applications go through the company's official careers site.

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Manufacturing Systems Engineer at Amgen, US - Puerto Rico - Juncos | Yoinka