Sr.Associate Systems Analyst (Validation Engineer)

Amgen Inc; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amgen Inc in Hyderabad, India is seeking a Systems Analyst for Clinical Study Design and Analysis. You will collaborate with network and infrastructure teams, support security patches, and validate business applications through regression and functional testing.

The role requires expertise in GxP computer system validation, Agile Scrum, and comprehensive validation methodologies to ensure compliant, reliable IT infrastructure and software delivery.

Qualifications

• Experience with GxP-regulated computer system validation.
• Experience with Agile software development methodologies (Scrum).
• Knowledge of validation solutions, tools, and methodologies.

Responsibilities

• Review system release notes and identify regression test requirements.
• Develop detailed test plans and strategies based on release notes and specifications.
• 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 plans, test cases, and test results.
• Maintain and ensure the quality of documented user stories/requirements in Jira.
• Prepare and report validation protocols in line with GxPs and other regulatory standards.
• Ensure validation test procedures comply with current technology and regulations.

Skills

GxP validation

Agile Scrum

Validation tools

Education

Masters or Bachelors

Job description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the worlds toughest diseases, and make peoples lives easier,fullerand longer. We discover, develop,manufactureand deliver innovative 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 beyondwhatsknown today.

ABOUT THE ROLE

Role 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 necessary
• Review system release notes andidentifyregression test requirements
• Develop detailed test plans and strategies based onrelease notes,project requirements,and specificationsdocuments
• Perform manual and automated testing of software applications, including functional, regression, and performance testing
• Document and report defects and issuesidentifiedduring testing, and work with development teams to resolve them
• Maintain detailed documentation of test/validation plans, test cases, and test results
• Advise onthe 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 toolssuch asJira
• Prepare, execute, document,and report validation protocols in line withGxPsand other regulatory requirements and standards
• Assure that all validation test procedures are in line with current technology, corporate,and governmental regulations
• PerformInstallationQualification, Operational Qualification, and PerformanceQualificationvalidation on processes, equipment, and systems in conjunction with suppliers as appropriate

Basic Qualifications and Experience:

• Masters degree ORBachelors degree with5-9years of experience inInformation Systems Administration/Support/Validation

Functional Skills:

Must-Have Skills:

• Experience withGxP-regulated computer systemvalidation
• Experience with Agile software development methodologies (Scrum)
• Experience with validation solutions, tools, and methodologies

Good-to-Have Skills:

• Experience draftingdocumentation in adherence to standard operating procedures
• Understanding of biostatistical analysis methods
• Experience withgenerativeartificial 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 beassigneda 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 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.