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Vacancy description

PLM Software Quality & Validation Engineer in Hyderabad, भारत

Amgen

Hyderabad, भारत

Amgen seeks a PLM Software Quality & Validation Engineer to develop, execute, and maintain test scripts for 3DEXPERIENCE PLM platforms and custom solutions. The role involves functional testing, test automation, validation documentation, and cross-functional collaboration in a cloud-based SaaS environment within a GxP-regulated pharmaceutical context.

Responsibilities

  • Develop and maintain comprehensive test plans for 3DEXPERIENCE platform modules and applications
  • Execute functional, system, stress, performance, integration, regression, and beta testing activities
  • Create validation documentation including plans, protocols, and reports aligned with regulatory requirements
  • Develop and maintain test automation scripts, frameworks, and CI/CD pipeline integration
  • Collaborate with cross-functional teams including QA, engineering, and platform teams to drive validation activities and meet deadlines

Requirements

  • 3+ years QA testing experience on 3DEXPERIENCE or similar PLM/enterprise software
  • 3+ years validation experience in GxP-regulated industry (pharma, biotech, medical devices)
  • Proficiency developing and executing validation protocols (IQ, OQ, PQ) and documentation
  • Experience with computer system validation and software validation methodologies
  • Bachelor's or Master's degree with 5-8 years software quality and GxP validation experience
  • Strong analytical and problem-solving skills with excellent communication abilities
  • Experience with test automation development, execution, and analysis

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