Sr. Manufacturing Systems Engineer (Automation Engineer)

Amgen • Juncos, PR

23h • Onsite

About The Position

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

SR. MFG SYSTEMS ENGINEER (AUTOMATION ENGINEER)

What you will do
Let’s do this. Let’s change the world. In this vital role you will focus on automation system reliability, control system design and improvements as well as supporting the digital transformation of manufacturing systems initiative, driving innovation, compliance, and operational excellence through groundbreaking automation and smart technologies. The emphasis aligns with Rockwell & AVEVA Wonderware/PLC automation, GMP compliance, commissioning, and lifecycle ownership.

Requirements

• Doctorate degree in Engineering
• Master’s degree in Engineering and 2 years of Manufacturing Systems/Automation experience
• Bachelor’s degree in Engineering and 4 years of Manufacturing Systems/Automation experience
• Demonstrated experience supporting automation systems in a regulated manufacturing environment.
• Experience with the design, configuration, installation, testing, commissioning, and lifecycle support of automation systems.
• Ability to support manufacturing operations, capital projects, and troubleshooting activities in an on-site production environment.
• Three or more years of combined experience with AVEVA Wonderware Intouch and Rockwell Automation PLC/SCADA platforms.
• Experience with virtual-server infrastructure, process-control networks, and industrial system integration.
• Direct experience in GMP biopharmaceutical manufacturing and process-equipment automation.
• Knowledge of computerized-system validation, data integrity, and applicable regulatory expectations.
• Experience leading complex capital projects or automation lifecycle/asset-management initiatives.
• Experience developing control strategies for new products, equipment, or manufacturing processes.
• Demonstrated record of continuous improvement that improved safety, reliability, efficiency, or operational performance.
• Experience leading investigations, change controls, deviations, CAPAs, and corrective actions.
• Ability to coach technical personnel and provide automation leadership to site teams.

Responsibilities

• Serve as a subject matter expert in manufacturing systems and digital technologies.
• Lead the implementation and support of MES, SCADA, PLC integration processes and other manufacturing IT Tier systems.
• Collaborate with multi-functional teams to define system requirements and ensure alignment with business needs.
• Develop and maintain system documentation, including user requirements, design specifications, and test plans.
• Troubleshoot system issues and coordinate resolution with IT and vendor support teams.
• Ensure system compliance with cGMP, data integrity, and cybersecurity requirements.
• Support system validation and change control activities.
• Analyze system performance data to identify trends and opportunities for optimization.
• Train users on system functionality and best practices.
• Participate in audits and inspections, providing system documentation and support.
• Drive continuous improvement initiatives related to manufacturing systems.
• Stay informed on new technologies and digital trends in manufacturing.
• Promote a culture of digital innovation and operational excellence.
• Problem Solving & Troubleshooting Skills
• AVEVA Wonderware Intouch configuration, programming, troubleshooting, and lifecycle management
• Rockwell Automation PLC, HMI, and SCADA systems, including programming and integration
• Process automation for biopharmaceutical manufacturing equipment and utilities
• Electronic batch reporting and recipe/batch-control system design
• Automation system commissioning, qualification, testing, and start-up support
• FAT/SAT execution, Automation Checkout, Installation Verification, and functional testing
• Process-control network architecture, segregation, virtualization, servers, and cybersecurity coordination
• System integration using OPC, Profibus, DeviceNet, Ethernet/IP, and OEM skid interfaces
• Field instrumentation, control valves, transmitters, calibration, and control-loop troubleshooting
• Development of automation specifications, functional design specifications, SOPs, and engineering standards
• Root-cause analysis, deviation investigation, CAPA, and change-control ownership
• Data-integrity assessments and lifecycle documentation for computerized systems
• GMP/GxP compliance and familiarity with 21 CFR Part 11, GAMP 5, ASTM E2500, ISA-88, ISA-95, and GDP
• Knowledge of upstream and downstream bioprocess unit operations, including media preparation, bioreactors, chromatography, filtration, UF/DF, and associated utilities
• Capital-project lifecycle support: conceptual design, scope development, cost estimates, detailed design, commissioning, validation, and handover
• Continuous-improvement methods focused on safety, reliability, throughput, efficiency, and sustainability

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree