Senior Engineer - Project Engineering
Company: Amgen
Location: Holly Springs
Posted on: January 12, 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 single use
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 Engineer - Project Engineering What you will do Lets
do this. Lets change the world. The Project Engineer is responsible
for providing strategic leadership, technical oversight, and
operational management for leading engineering and qualification of
small project implementation. This role ensures compliant,
efficient, and consistent validation practices across departmental
capital projects, site initiatives, and ongoing system lifecycle
activities. The position requires strong technical acumen,
cross-functional collaboration, and the ability to drive both local
and network-level improvements. Serve as Qualification Lead for
departmental capital projects, overseeing contracted resources,
documentation, CCMS assessments, and project alignment. Partner
with project leads to scope new work, estimate efforts, and assign
engineering resources. Manage the full lifecycle of the validation
maintenance program, including development of the annual scope of
work, cost negotiations, PO issuance, and leading progress
meetings. Drive inspection readiness by maintaining playbooks,
responding to inspection IRFs, and presenting qualification topics
to auditors. Support construction and capital project teams by
providing oversight as the role continues to expand. Lead
efficiency improvements by developing automation/AI tools for
periodic reviews and audit trail assessments. Participate in global
qualification, computerized systems, and data integrity networks
and share updates with site teams. May own and manage deviations as
assigned. What we expect of you We are all different, yet we all
use our unique contributions to serve patients. The project
engineer professional sought for this role will exemplify these
values and possess the qualifications outlined below. Basic
Qualifications: High school diploma / GED and 12 years of Project
Implementation and Qualification experience OR Associates degree
and 10 years of Project Implementation and Qualification experience
OR Bachelors degree and 6 years of Project Implementation and
Qualification experience OR Masters degree and 4 years of Project
Implementation and Qualification experience OR Doctorate degree and
4 years of Project Implementation and Qualification experience
Preferred Qualifications: Demonstrated leadership experience in
managing technical teams or leading complex cross-functional
initiatives. Strong understanding of GMP regulations, validation
lifecycle requirements, data integrity principles, and
qualification best practices. Experience serving as a project or
qualification lead on capital projects. Ability to interface with
auditors and respond to regulatory inspection requests. Familiarity
with automated systems, CCMS/CMMS platforms, and AI/automation
tools for compliance workflows. Excellent communication,
stakeholder engagement, and decision-making skills. Ability to
manage competing priorities in a dynamic environment and influence
without authority. Strong analytical skills and ability to
translate technical data into clear, actionable insights. Prior
experience within the pharmaceutical, biotechnology, or regulated
life sciences industry strongly desired. 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, Raleigh , Senior Engineer - Project Engineering, Engineering , Holly Springs, North Carolina
