Sr. Manufacturing Systems Engineer (Automation Engineer)
Amgen
Summary
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.
Job description
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
Basic Qualifications
- Doctorate degree in Engineering
- Or Master’s degree in Engineering and 2 years of Manufacturing Systems/Automation experience
- Or Bachelor’s degree in Engineering and 4 years of Manufacturing Systems/Automation experience
Preferred Qualifications
- 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.
Requirements
- Doctorate degree in Engineering
- Or Master’s degree in Engineering and 2 years of Manufacturing Systems/Automation experience
- Or 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.
Benefits
- Retirement and Savings Plan
- Medical, Dental & Vision
- Life & Disability Insurance
- Annual Bonus Program
- Stock-based Long-term Incentives
- Paid Time Off
- Annual Site Shutdown
- Flexible Work Models
- Career Development Opportunities
Company overview
Amgen Inc. is a leading American multinational biopharmaceutical company headquartered in Thousand Oaks, California, founded in 1980. As one of the world's largest independent biotechnology companies, Amgen specializes in discovering, developing, manufacturing, and delivering innovative human therapeutics. The company focuses on six key therapeutic areas: inflammation, oncology/hematology, bone health, cardiovascular disease, nephrology, and neuroscience. Amgen's portfolio includes blockbuster drugs such as Enbrel for autoimmune diseases, Prolia and XGEVA for osteoporosis, Repatha for cholesterol management, Otezla for psoriasis, and Neulasta for chemotherapy-induced neutropenia. With approximately 28,000 employees worldwide, Amgen operates as a component of both the Dow Jones Industrial Average and Nasdaq-100 indices. The company maintains a robust research and development pipeline with numerous clinical programs across various stages, leveraging cutting-edge biotechnology and human genetic data to address some of the world's most challenging diseases. Amgen's manufacturing capabilities span multiple global locations, and it distributes products through pharmaceutical wholesale distributors and direct-to-consumer channels.