Amgen
Biotechnology
SeniorValidationLeadandSystemAdministrator
Neural analysis suggests this role is
optimal for Senior candidates.
“Senior Validation Lead and System Administrator at Amgen. Skills: Validation Lead, System Administrator, Clinical Study Design, Clinical Trial Analysis. Lead validation and operational management of business applications. Monitor and advise on process adherence”
What You'll Achieve.
Ensuring the integrity and compliance of critical systems and data; Ensuring critical systems maintain a validated state for business continuity; Ensuring the uptime, performance, and security of IT infrastructure; Prioritizes business continuity and compliance with standard procedures
Industry & Context.
Excellent analytical and troubleshooting skills
What They're Looking For.
Must Have
Master's degree OR Bachelor's degree with 8 - 13 years of experience in Information Systems Administration/Support/Validation, Experience with GxP regulated computer system validation, Proficiency in the support and management of business applications, both Commercial off the shelf and custom-built
Nice to Have
Agile software development methodologies (Scrum), Biostatistical analysis methods, Generative artificial intelligence, Agentic AI, Emerging technologies, Scaled Agile Framework (SAFe) certification, AWS certifications including cloud practitioner/solutions architect/sysops administrator
What You'll Do.
Lead validation and operational management of business applications
Monitor and advise on process adherence
Ensure critical systems maintain validated state
and operate computer systems
Manage cloud environments
Safeguard sensitive information
and security of IT infrastructure
Develop detailed test plans and strategies
Assure validation test procedures align with regulations
Lead and advise on manual and automated testing
Document and report defects
Maintain detailed documentation of test/validation plans
Validate test scenarios meet acceptance criteria
Maintain and ensure quality of documented user stories/requirements
Perform or support Installation Qualification
Operational Qualification
and Performance Qualification
Configure and maintain servers and applications
Implement and maintain security measures
Provide escalation-point for technical support
Apply operating system updates
and configuration changes
Maintain detailed documentation of system configurations
Manage disaster recovery processes
Ensure delivery of new features
How You'll Work.
Team & Collaboration
Collaborates regularly with key business stakeholders; Collaborates with project delivery team-members; Collaborates with application support team-members; Collaborates with quality teams; Work with development teams to resolve defects; Work closely with implementation and project delivery team-members
Communication Scope
Excellent communication skills; Interface with senior leadership with confidence and clarity; Verbal and written communication skills
Process & Methodology
Change Control, Project Delivery
Full Job Description
## **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. This role is accountable for monitoring and advising on process adherence in system implementations and change control, ensuring critical systems maintain a validated state for business continuity. In addition, the role is responsible for the monitoring, maintenance, and reliable operation of computer systems, servers, integrations, and databases. This role involves managing cloud 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, project 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 issue
Applying for this Senior Validation Lead and System Administrator role?
Most applicants get filtered before a human reads their resume. See if yours makes the cut.
How to Apply on Workday
- Workday has a multi-step form — save your progress after every section.
- "Apply With LinkedIn" can fail or lose data; manual entry is more reliable.
- Watch for the "Submit for Review" final step — hitting "Save" alone does not submit.
- Job requisition numbers are useful when following up with HR by email.
ANONYMOUS · UNFILTERED
What do employees actually say about Amgen?
Real rants from real employees. Read before you apply.