Sr.Associate Systems Analyst (Validation Engineer)

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 .  

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