Senior Manufacturing Systems Engineer: Automation - DeltaV
Company: Amgen
Location: Holly Springs
Posted on: January 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. Senior Manufacturing Systems Engineer: Automation - DeltaV
What you will do Lets do this. Lets change the world. As a Senior
Manufacturing Systems Engineer, you will provide automation
technical leadership to 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. Site design, construction, start-up, and
operational readiness 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 Support design phases 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 Collaborate with cross-functional teams to develop a
robust commissioning and qualification plan and/or qualification
strategy Support commissioning and qualification including
Automation Installation Verification/Automation Check Out (IV/ACO)
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 Site
Operations Own and drive to completion Change Controls, CAPAs, and
Deviations Lead and support technical root cause analysis, incident
investigations, and troubleshooting Lead and 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 Perform and maintain Data Integrity Assessments
(DIA) in accordance with the current Amgen and industry standards
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 10 years of engineering
experience OR Associates degree and 8 years of engineering
experience OR Bachelors degree and 4 years of engineering
experience OR Masters degree and 2 years of engineering experience
OR Doctorate degree Preferred Qualifications: Degree in Electrical
Engineering, Computer Science, Chemical Engineering, Biotech
Engineering, or related field Direct knowledge of automation system
design Experience in programming, installation and lifecycle
management of automation and field instrumentation technologies
Experience in automation of GMP biopharmaceutical equipment and
systems such as buffer prep and hold, chromatography, single use
mixing vessels, depth filtration, and solution prep Experience in
integrating various OEM automation software 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
leadership, technical writing, and communication skills Ability for
domestic and international travel 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 , Senior Manufacturing Systems Engineer: Automation - DeltaV, Engineering , Holly Springs, North Carolina
