Career Category
Project Management
Job Description
Join Amgen’s Mission of Serving Patients
Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier,
fuller
and longer. We discover, develop,
manufacture
and deliver innovative medicines to help millions of patients. Amgen helped
establish
the biotechnology industry more than 40 years ago and
remains
on the
cutting-edge
of innovation, using technology and human genetic data to push beyond
what’s
known today.
At Amgen, if you feel like
you’re
part of something bigger,
it’s
because you are. Our shared mission
to serve patients living with serious illnesses
drives all that we do.
Since 1980,
we’ve
helped pioneer the world of biotech in our fight against the world’s 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,
you’ll
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,
you’ll
thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
What you
will do
Let’s
do this.
Let’s
change the world.
In this critical role, you will serve as the end-to-end Change Owner for SAP
/
ERP
portfolio
, ensuring that all system changes are planned, assessed, implemented,
validated
, and released in compliance with
GxP
regulations, Amgen IT-QMS
and change management process
aligned to
global
best practices
.
You will partner closely with Business, ERP
product
delivery teams, Validation, and Quality to enable risk-based, audit-ready, and efficient change execution across Amgen’s SAP landscape.
Roles & Responsibilities:
Act as the single point of accountability for SAP ERP changes across projects, enhancements, fixes, and operational maintenance.
Own and execute the change lifecycle including:
Change initiation and classification
Impact and risk assessment
Approval coordination (
Change managers,
Business,
SMEs,
Quality, CAB)
Implementation oversight
Post-implementation verification and closure
Ensure all SAP changes
comply with
:
21 CFR Part 11
/
EU Annex 11
regulations
ALCOA+ data integrity principles
GAMP 5 and CSA (Computer Software Assurance)
Partner with
Quality and Compliance
to:
Assess validation impact of changes
Assess
required validation deliverables
Ensure traceability between requirements, risks, testing, and release
Support SAP platforms including ECC, S/4HANA, BTP, GRC, Solution
Manager
(
Solman)
, integrations, and boundary systems.
Ensure changes
maintain
effective controls for:
User access and segregation of duties
Audit trails and logging
Configuration vs. customization decisions
Coordinate with SAP
development,
functional
, testers and
SME’s
to ensure
timely
and compliant
deployment
of changes.
Support release planning, cutover activities, and
hypercare
as
required
.
Maintain audit-ready documentation and evidence for change, validation, incident, and deviation activities.
Proactively
identify
opportunities to simplify
and
optimize
change processes, reduce rework, and improve cycle time while
maintaining
quality and
compliance.
Contribute to continuous improvement initiatives
across the Change management
, including adoption of digital validation, automation, and standardized templates.
Support internal and external audits by providing change-related evidence and responding to audit inquiries
What we expect
of
you
We are all different, yet we all use our unique contributions to serve patients.
Basic Qualifications and Experience:
Master’s degree and
3
+
years of Computer Science, IT
/Lifesciences Change Management with
Computerized systems Validation/
Assurance
(
CSV/CSA)
understanding
in a
G
x
P
regulated environment
OR
Bachelor’s degree and
5
+
years of Computer Science,
T
/Lifesciences Change Management with
Computerized systems Validation/Assurance
understanding
in a
G
x
P
regulated environment
OR
Diploma and
8
+
years of Computer Science,
I
T
/Lifesciences Change Management with
Computerized
systems
Validation/Assurance
understanding
in a
G
x
P
regulated environment
.
Hands-on experience supporting SAP ERP systems in a
GxP
-regulated environment
Strong working knowledge of:
IT Change Management
Strong understanding of SAP ERP landscapes
Validation and compliance processes
Regulatory requirements (21 CFR Part 11, Annex 11, ALCOA+, GAMP 5)
Experience working within structured SDLC
, Agile
, Transport Management
and IT-QMS frameworks.
Preferred Qualifications:
Experience supporting SAP transformation initiatives (
Ex:
R/3 to ECC and/or
ECC
to
S/4HANA upgrades
).
Familiarity with
CSA-aligned, risk-based validation approaches
and
Hands
on experience preparing change and validation documentation
.
Experience working with ITSM and change management tools (
Ex
., ServiceNow
, Solman
).
Exposure to audits or inspections supporting SAP systems.
Experience working in global, matrixed teams.
Professional Certifications
Scrum Master
or equivalent
ITIL / Change Management certification
Soft Skills:
S
trong
sense of ownership and accountability
Excellent communication and stakeholder-management skills
Ability to balance compliance requirements with business agility
Structured, detail-oriented, and risk-aware mindset
Comfortable working across Business, IT, and Quality teams
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,
we’ll
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.
EQUAL OPPORTUNITY STATEMENT
Amgen is an Equal Opportunity employer and will consider you without regard to your race,
color
, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We
Reasonable accommodation will be provided to individuals with disabilities to
participate
in the job application or interview process and to perform essential job functions.
Apply now
F
or a career that defies imagination
Objects in your future are closer than they appear. Join us
at
careers.amgen.com
.
