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

PLM Software Quality & Validation Engineer

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