PLM Software Quality & Validation Engineer

Amgen · Hyderabad, India

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Role summary

Amgen seeks a PLM Software Quality & Validation Engineer in Hyderabad to ensure product lifecycle management solutions meet validation standards and regulatory requirements. The role involves test planning, automation, and documentation across the 3DExperience platform in a GMP-regulated environment.

What they're looking for

Master's or Bachelor's degree with 5–9 years of software quality and GMP validation experience
QA testing expertise on 3DExperience platform or similar PLM/enterprise software
Validation experience in GMP-regulated industries (pharmaceutical, biotech, medical devices)
Proficiency in developing and executing validation protocols (IQ, OQ, PQ) and related documentation
Strong analytical and problem-solving skills with computer system validation knowledge
Excellent verbal and written communication abilities

What you'll be doing

Develop and maintain comprehensive test plans for 3DExperience platform modules and applications
Execute functional, system, stress, performance, integration, and regression testing in Agile environments
Create validation documentation including plans, protocols, and reports aligned with regulatory requirements
Design and implement automated test suites, analyze results, and perform root cause analysis
Collaborate with cross-functional teams on validation activities, UAT, and test data preparation

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Date posted16 days ago

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