Sr. Manufacturing Systems Engineer (Automation Engineer)

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 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. Specific responsibilities include but are not limited to: 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The Sr. Mfg Systems Engineer professional we seek is an individual contributor with these qualifications. 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. 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. 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 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. .