Career CategoryEngineering
Job DescriptionSR. MFG SYSTEMS ENGINEER (AUTOMATION ENGINEER)What you will doLet'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 youWe 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 usAs 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.careers.amgen.comIn 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.
SponsorshipSponsorship of this role is not guaranteed.
