Career Category
Information Systems
Job Description
ABOUT AMGEN
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.
ABOUT THE ROLE
Role Description:
The
Systems Analyst
– Clinical
Study Design and Analysis
will collaborate with
network and
infrastructure
administrators in the security-patching lifecycle and maintenance of the infrastructure supporting our business applications,
safeguarding sensitive
information
and
ensuring the uptime, performance, and security of IT infrastructure
.
In addition, the Systems Analyst will be
come subject matter experts in the Business
Applications, and
will
manage and
perform the
routine regression-testing, as well as
functional and non-functional testing for projects and enhancements.
This role involves working closely with
business partners to understand
business processes supported by the applications, as well as working closely with
Software-as-a-Service suppliers to review and understand release notes
and how system updates will
impact
business processes. This role also interacts regularly with
developers
and
business analysts to ensure that the
technical requirements for upcoming development are thoroughly
elaborated
and documented in a testable manner
. This
enabl
es
the delivery team to estimate, plan, and commit to delivery with high confidence
and
identify
test cases and scenarios
to ensure the quality and performance of IT Systems
.
This role collaborates regularly with business
analysts,
members of the Quality
team, developers
, product managers,
system
/
network administrators
, and application support team members
to
maintain
an efficient and consistent process, ensuring
business applications
maintain
a reliable and validated state.
Roles & Responsibilities:
Support
,
monitor
, or
execute the installation
of infrastructure security
patches
and configuration changes
,
as necessary
Review system release notes and
identify
regression test requirements
Develop detailed test plans and strategies based on
release notes,
project requirements
,
and specifications
documents
Perform manual and automated testing of software applications, including functional, regression, and performance testing
Document and report defects and issues
identified
during testing, and work with development teams to resolve them
Maintain detailed documentation of test/validation plans, test cases, and test results
Advise on
the documentation of requirements to ensure that they are written in a testable manner
Validate that test scenarios meet feature acceptance criteria and customer expectations
Maintain and ensure the quality of documented user stories/requirements in tools
such as
Jira
Prepare, execute, document
,
and report validation protocols in line with
G
x
P’s
and other regulatory requirements and standards
Assure that all validation test procedures are in line with current technology, corporate
,
and governmental regulations
Perform
I
nstallation
Q
ualification
, O
perational Qualification
, and P
erformance
Q
ualification
validation on processes, equipment, and systems in conjunction with suppliers as appropriate
Basic Qualifications and Experience:
Master’s degree
OR
Bachelor’s degree with
5
-
9
years of experience in
Information Systems Administration/Support/Validation
Functional Skills:
Must-Have Skills
:
Experience with
GxP
-
regulated computer system
validation
Experience with Agile software development methodologies (Scrum)
Experience with validation solutions
, tools, and methodologies
Good-to-Have Skills:
Experience drafting
documentation in adherence to standard operating procedures
Understanding of biostatistical analysis method
s
Experience with
generative
artificial intelligence, agentic AI, and other emerging technologies
Professional Certifications
:
Certified Tester/Agile Tester or similar (preferred)
Scaled Agile Framework (
SAFe
)
certification (preferred)
Soft Skills:
Able to work under minimal supervision
Strong verbal and written communication skills
Ability to work effectively with global, virtual teams
High degree of initiative and self-motivation
Ability to manage multiple priorities successfully
Team-oriented, with a focus on achieving team goals
Strict attention to detail and process adherence
Shift Information:
This position requires you to work a later shift and may be
assigned
a second or third shift schedule. Candidates must be willing and able to work during evening shifts.
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 will ensure that individuals with disabilities are provided with 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
.
.
