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Software Quality & Validation Engineer

Fresher   Hyderabad, Telangana   28 Oct, 2025
Amgen
Job LocationHyderabad, Telangana
EducationNot Mentioned
SalaryNot Disclosed
IndustryMedical / Healthcare
Functional AreaNot Mentioned
EmploymentTypeFull-time

Job Description

    Role Overview:As a skilled PLM Software Quality & Validation Engineer at Amgen, your primary responsibility will be to develop, execute, and maintain test scripts for 3DEXPERIENCE PLM platforms and custom-built solutions. You will play a crucial role in ensuring that the PLM solutions adhere to required validation processes, documentation, and comply with Amgens standard operating procedures. Your expertise will be instrumental in guaranteeing quality and adherence to standards, enabling the engineering teams to build and deploy compliant products efficiently.Key Responsibilities:- Work on various types of testing including Functional, System, Stress, Performance, Integration, Regression, and Beta in web applications.- Develop and maintain comprehensive test plans for 3DExperience platform modules and applications.- Actively participate in release planning and estimate test efforts.- Analyze and communicate test results in an Agile development environment.- Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.- Ensure validation strategies meet regulatory requirements and company standards.- Assist with UAT, test data preparation, and work instructions development.- Contribute to test automation scripting, framework maintenance, and CI/CD integration.- Execute automated test suites across various modules in 3DEXPERIENCE.- Analyze test automation results, identify failures, and assist in root cause analysis.- Collaborate with cross-functional teams to drive validation activities and meet project deadlines.- Document all bugs in a tracking tool and follow best QA practices.- Identify opportunities for process improvements in validation activities.- Stay updated on new technologies, validation trends, and industry best practices.Qualifications Required:- Must have at least 3 years of experience in Quality Assurance (QA) testing, specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions.- Minimum 3 years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.).- Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.- Strong problem-solving and analytical skills.- Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable.- Experience with automated and computer-controlled systems validation (21 CFR Part 11).Additional Details:Amgen is committed to providing equal opportunities to individuals with disabilities. Reasonable accommodations will be provided to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Feel free to contact us to request an accommodation.,

Keyskills :
Quality AssuranceQA testingValidationTest AutomationComputer System ValidationSoftware ValidationAnalytical skills3DEXPERIENCE platformPLMenterprise software solutionsGxPregulated environment

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