Plm Software Quality & Validation Engineer

Amgen Inc

3dexperience platform experience
Gxp regulated environment validation
Iq oq pq protocol development
Amgen is seeking a skilled engineer to develop and maintain test scripts for the 3DEXPERIENCE PLM platform in a GxP-regulated environment

Job Summary

  • Amgen is seeking a skilled engineer to develop and maintain test scripts for the 3DEXPERIENCE PLM platform in a GxP-regulated environment.
  • The role involves creating comprehensive validation documentation including IQ, OQ, and PQ protocols while ensuring compliance with regulatory standards.
  • Candidates will collaborate with cross-functional teams to drive validation activities, execute automated test suites, and contribute to process improvements.

Matching Summary

Amgen is seeking a skilled engineer to develop and maintain test scripts for the 3DEXPERIENCE PLM platform in a GxP-regulated environment.

Skills & Requirements

Must-have

  • 3DEXPERIENCE platform experience
  • GxP regulated environment validation
  • IQ OQ PQ protocol development
  • Computer system validation expertise
  • Functional and test automation skills

Nice-to-have

  • 21 CFR Part 11 compliance knowledge
  • Agile development environment experience
  • CI/CD integration capabilities
  • Strong presentation and communication skills
  • Global virtual team collaboration

Key Requirements

  • 3+ years QA testing on 3DEXPERIENCE or similar PLM
  • 3+ years validation in GxP regulated environment
  • Bachelor's or Master's degree required
  • 5-8 years total experience in Software Quality

Work Rights

Not specified

Tailored Resume

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