ABOUT AMGENAmgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier,fullerand longer. We discover, develop,manufactureand deliver creative medicines to help millions of patients. Amgen helpedestablishthe biotechnology industry more than 40 years ago andremainson thecutting-edgeof innovation, using technology and human genetic data to push beyondwhat’sknown today.ABOUT THE ROLERole Description:TheSystems Analyst– ClinicalStudy Design and Analysiswill collaborate withnetwork andinfrastructureadministrators in the security-patching lifecycle and maintenance of the infrastructure supporting our business applications,safeguarding sensitiveinformationandensuring the uptime, performance, and security of IT infrastructure.In addition, the Systems Analyst will become subject matter experts in the BusinessApplications, andwillmanage andperform theroutine regression-testing, as well asfunctional and non-functional testing for projects and enhancements.This role involves working closely withbusiness partners to understandbusiness processes supported by the applications, as well as working closely withSoftware-as-a-Service suppliers to review and understand release notesand how system updates willimpactbusiness processes. This role also interacts regularly withdevelopersandbusiness analysts to ensure that thetechnical requirements for upcoming development are thoroughlyelaboratedand documented in a testable manner. Thisenablesthe delivery team to estimate, plan, and commit to delivery with high confidenceandidentifytest cases and scenariosto ensure the quality and performance of IT Systems.This role collaborates regularly with businessanalysts,members of the Qualityteam, developers, product managers,system/network administrators,



and application support team memberstomaintainan efficient and consistent process, ensuringbusiness applicationsmaintaina reliable and validated state.Roles & Responsibilities:Support,monitor, orexecute the installationof infrastructure securitypatchesand configuration changes,as necessaryReview system release notes andidentifyregression test requirementsDevelop detailed test plans and strategies based onrelease notes,project requirements,and specificationsdocumentsPerform manual and automated testing of software applications, including functional, regression, and performance testingDocument and report defects and issuesidentifiedduring testing, and work with development teams to resolve themMaintain detailed documentation of test/validation plans, test cases, and test resultsAdvise onthe documentation of requirements to ensure that they are written in a testable mannerValidate that test scenarios meet feature acceptance criteria and customer expectationsMaintain and ensure the quality of documented user stories/requirements in toolssuch asJiraPrepare, execute, document,and report validation protocols in line withGxP’sand other regulatory requirements and standardsAssure that all validation test procedures are in line with current technology, corporate,and governmental regulationsPerformInstallationQualification, Operational Qualification, and PerformanceQualificationvalidation on processes, equipment,



and systems in conjunction with suppliers as appropriateBasic Qualifications and Experience:Master’s degree OR Bachelor’s degree with 5- 9years of experience inInformation Systems Administration/Support/ValidationFunctional Skills:Must-Have Skills:Experience withGxP-regulated computer systemvalidationExperience with Agile software development methodologies (Scrum)Experience with validation solutions, tools, and methodologiesGood-to-Have Skills:Experience draftingdocumentation in adherence to standard operating proceduresUnderstanding of biostatistical analysis methodsExperience withgenerativeartificial intelligence, agentic AI, and other emerging technologiesProfessional Certifications:Certified Tester/Agile Tester or similar (preferred)Scaled Agile Framework (SAFe)certification (preferred)Soft Skills:Able to work under minimal supervisionStrong verbal and written communication skillsAbility to work effectively with global, virtual teamsHigh degree of initiative and self-motivationAbility to manage multiple priorities successfullyTeam-oriented, with a focus on achieving team goalsStrict attention to detail and process adherenceShift 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 STATEMENTAmgen 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 toparticipatein the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to requestaccommodation.

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