Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation
Amgen
- Location
- US - North Carolina - Holly Springs
- Work model
- On-Site
- Level
- Principal
- H-1B history
- 137 approvals (FY2023)
- Posted
- Sep 8, 2026
About this role
Career Category Engineering Job Description HOW MIGHT YOU DEFY IMAGINATION? You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience, and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Principal Manufacturing Systems Engineer – Upstream/Downstream Process Automation What you will do Let’s do this! Let’s change the world! In this vital role, you will serve as a subject matter expert in automation engineering, driving innovation, solving complex challenges, and influencing the design and implementation of automation systems for upstream and downstream bioprocessing. You will collaborate across engineering, manufacturing, and quality teams to ensure robust, compliant, and scalable automation solutions that support 24/7 operations. The Principal Manufacturing Systems Engineer will join the Facilities & Engineering (F&E) group. This role will partner closely with the corporate engineering team during the design, build, commissioning, and qualification phases and later transitioning to supporting daily operations for drug substance production. This role will be instrumental in developing automation domain expertise and supporting operational readiness. Job responsibilities include: Site design, construction, start-up, and operational readiness: Support design reviews while partnering closely with the corporate engineering team to represent site interests and requirements. Execute and support the commissioning and qualification of process equipment automation in alignment with GMP requirements, while working in partnership with global engineering during site installation. Ensure their operational capability is aligned with manufacturing requirements and GMP regulation and on-time project delivery. Collaborate with the site process engineering team to understand key process requirements and develop process control automation solutions primarily utilizing Emerson DeltaV Distributed Control System (DCS). Lead commissioning and qualification efforts, including Automation Installation Verification/Automation Check Out (IV/ACO), ensuring compliance with GMP and project timelines. Partner with various organizational units to support tasks including operational readiness, document reviews, deviation investigation and change controls. Provide mentoring to develop and accelerate site technical automation capabilities. Site Operations: Act as responsible system owner for automation systems, providing day-to-day automation support including 24 x 7 onsite/on-call support, troubleshooting, and daily automation team meetings. Provide technical leadership to troubleshoot, identify and resolve process and system issues as needed. Effectively collaborate with key customers and support groups (e.g. Manufacturing, Quality, Process Development, Maintenance, network partners). Perform automation change assessments, implement automation system configuration changes, and support engineering and process qualification runs. Lead continuous improvement initiatives including improvements to safety,