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 Sr. Validation Engineer – Clinical
Study Design and Analysis
will
lead
the validation and operational management of
business applications
used
in
the support of the
design
of clinical trials
at Amgen, ensuring the integrity and compliance of critical systems and data.
T
his role is
accountable for
monitoring
and
advising on
process adherence in system
implementations and
change
control,
ensuring
critical systems
maintain
a validated
state
f
or
business continuity
.
In addition, t
he
role
is responsible for
the
monitoring
,
maintenance, and reliable operation of computer systems
,
servers
, integrations, and databases
.
This role involves managing
c
loud
environments,
Software
-
as
-
a
-
Service applications, custom-developed applications,
and
integrations
,
with a focus on
safeguarding sensitive information
and
ensuring the uptime, performance, and security
of IT infrastructure
. This role collaborates
regularly
with
key
business stakeholders,
pro
ject delivery
team-members
, application support
team
-members
, and quality
teams
.
Roles & Responsibilities:
Develop detailed test plans and strategies based on project requirements and specifications
Assure that all validation test procedures are in line with current technology, corporate, and governmental regulations
Lead and advise on
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
aligned to
Standards and Standard Operating Procedures
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
Perform
or support
I
nstallation
Q
ualification
, O
perational Qualification
, and P
erformance
Q
ualification
validation on processes, equipment, and systems in conjunction with suppliers as appropriate
C
onfigure and
maintain
servers and applications to ensure their reliability and performance
Implement and
maintain
security measures to protect systems from unauthorized access, vulnerabilities, and other threats
Provide
an escalation-point for
technical support to users, troubleshooting and resolving issues related to system access, performance, and software
Apply operating system updates, patches, and configuration changes as necessary
Maintain detailed documentation of system configurations, procedures, and change management
Manage
disaster
recovery processes to ensure data
and systems are
protected and can be restored quickly in case of a failure
Work closely with
implementation
and project delivery
team-members to
ensure delivery of new features, functionality, and releases
is performed in a manner that
prioritizes
business continuity and compliance with
standard procedures
Basic Qualifications and Experience:
Master’s degree
OR Bachelor’s degree with 8 - 13 years of experience in
Information Systems
Administration/Support/Validation
Functional Skills:
Must-Have Skills :
Excellent communication skills and the ability to
interface with
senior leadership with confidence and clarity
Experience with
GxP
regulated
computer system
validation
Proficiency
in
the
support and management of business
application
s
, both Commercial off the shelf and custom-built.
Good-to-Have Skills:
Experience with Agile software development methodologies (Scrum)
Understanding of
bio
statistical analysis
methods
Experience with
generative
artificial intelligence
, agentic AI,
and other emerging technologies
Professional Certifications
:
Scaled Agile Framework (
SAFe
)
certification (preferred)
AWS
certifications
including
cloud practitioner/solutions architect/sysops administrator (preferred)
Soft Skills:
Strong verbal and written communication skills
Excellent
understanding and adherence to
standard operating procedures
Excellent
analytical and troubleshooting skills
Ability to work effectively with global, virtual teams
High degree of initiative
, task ownership,
and self-motivation
Ability to manage multiple priorities successfully
Team-oriented, with a focus on achieving team goals
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
an accommodation
.
.
