Manufacturing Systems Engineer: Automation
Company: Amgen
Location: Holly Springs
Posted on: February 8, 2026
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Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds 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, youll 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, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. 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. Manufacturing Systems Engineer: Automation What you will do
Lets do this. Lets change the world. As a Manufacturing Systems
Engineer, you will work with a group of automation engineers who
are responsible for building and maintaining various automation
systems and platforms that support the GMP Drug Substance Plant
Operations. In this vital role as a member of the Facilities &
Engineering (F&E) Automation team you will work hand in hand
with the capital project team to deliver robust process automation
systems to operate the new plant. Develop and maintain the process
control system on Emerson DeltaV distributed control system (DCS).
Collaborate with key stakeholders and end-users to understand and
synthesize key process requirements, and to develop solutions using
Amgen standard automation platform for process automation systems.
Provide clear documentation for delivered solutions and processes.
Support QA partners in performing computerized systems validation
in a GxP environment. Perform Data Integrity Assessments (DIA) in
accordance with the current Amgen and industry standards. Support
process automation systems to ensure design aligns with Amgen
specifications, incorporates the latest technology, and meets
safety requirements. Support vendor FAT to ensure that control
strategy and software code meet Amgen requirements. Develop and
maintain engineering and maintenance documentation, and associated
procedures for delivered solutions and processes. Support
commissioning and qualification efforts including Automation
Installation Verification/Automation Check Out (IV/ACO) in a
fast-paced environment. Site Operations Own and drive to completion
Change Controls, CAPAs, and Deviations. Support technical root
cause analysis, incident investigations, and troubleshooting.
Support functional area projects focused on improving process
equipment, utilities, and facilities as well as large capital
projects to integrate new drug substance manufacturing technologies
into the facility. Drive continuous improvement for process
automation systems to improve operational workflows, safety,
reliability, efficiency, and sustainability. Support day-to-day
operations including rotational on-call support. Prepare/review
Standard Operating Procedures (SOP) and cGMP documents. Be
constantly curious and feed your passion and interests in
groundbreaking technology. Use your given time to look for new and
innovative ways to do business differently, better, and more cost
effectively. What we expect of you We are all different, yet we all
use our unique contributions to serve patients. The automation
professional we seek is an engineer with these qualifications.
Basic Qualifications: High School Diploma / GED and 8 years of
Engineering experience OR Associates Degree and 6 years of
Engineering experience OR Bachelors Degree and 2 years of
Engineering experience OR Masters Degree Preferred Qualifications:
Degree in Electrical Engineering, Computer Science, Chemical
Engineering, Biotech Engineering, or related field. Direct
knowledge of Automation System design, experience in process
control engineering and troubleshooting with GMP biopharmaceutical
production facility equipment/systems automation such as media,
harvest, bioreactors, solution prep, single use mixing vessels,
chromatography, TFFL/TFFX, viral filtration, viral inactivation,
UF/DF, depth filtration, drug substance fill, CIP/SIP, clean
utilities, and integrating various OEM automation software.
Experience in programming, installation, and lifecycle management
of automation and field instrumentation technologies. Experience in
programming, design, installation and lifecycle management of
manufacturing process controls, and automation and field
instrumentation technologies. Experience with Emerson DeltaV DCS
system and ability to perform advanced troubleshooting, and system
integration using OPC, Foundation Fieldbus, and Profibus
technologies. Ability to interpret and apply GAMPs and GMPs, and
familiarity with documentation in a highly regulated environment
with requirements such as 21 CFR Part 11, ASTM 2500, S88 and S95.
Self-directed team player able to work cross-functionally. Strong
technical writing and communication skills. What you can expect of
us As we work to develop treatments that take care of others, we
also work to care for your professional and personal growth and
well-being. From our competitive benefits to our collaborative
culture, well support your journey every step of the way. In
addition to the base salary, Amgen offers competitive and
comprehensive Total Rewards Plans that are aligned with local
industry standards. Apply now and make a lasting impact with the
Amgen team. careers.amgen.com 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 all qualified
applicants for employment without regard to race, color, religion,
sex, sexual orientation, gender identity, national origin,
protected veteran status, disability status, or any other basis
protected by applicable law. We will ensure that individuals with
disabilities are provided 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.
Keywords: Amgen, Greensboro , Manufacturing Systems Engineer: Automation, Engineering , Holly Springs, North Carolina
