Sr. Manufacturing Systems Engineer (Automation Engineer)
Amgen Inc. (IR)
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Benefits offered by this job
Job summary
Amgen Inc. is seeking a Senior Manufacturing Systems Engineer (Automation) to advance automation reliability and digital transformation in biopharmaceutical manufacturing.
You will focus on AVEVA Wonderware Intouch and Rockwell PLC/SCADA integration, ensuring cGMP compliance, data integrity, and lifecycle ownership across projects. The role involves leading automation design, validation, and change-control activities, collaborating with cross-functional teams, and driving continuous improvement
Qualifications
- Advanced degree in engineering required with relevant manufacturing automation experience.
- Experience with regulated manufacturing environments and systems.
- Ability to lead automation lifecycle activities and capital projects.
Responsibilities
- Serve as SME in manufacturing systems and digital technologies.
- Lead MES/SCADA/PLC integration and related IT tier systems.
- Collaborate with multifunctional teams to define system requirements.
- Develop and maintain system documentation and test plans.
- Troubleshoot system issues and coordinate with IT/vendor support.
- Ensure compliance with cGMP, data integrity, and cybersecurity.
Skills
Education
Tools
Job description
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.
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.
- 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
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.
- 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.
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.
Sponsorship of this role is not guaranteed.
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen
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