PLM Software Quality & Validation Engineer
Core
Ensure PLM solutions follow validation processes, documentation, and align with Amgen's standards to enable compliant product deployment.
Role type
Software Quality & Validation Engineer (PLM/GMP)
Builds
3DExperience platform modules and applications
Domain
Pharmaceutical/Biotech + PLM/Enterprise Software
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP validation, 3DEXPERIENCE platform testing, QA testing (Functional/System/Performance/Integration/Regression/Beta), validation protocols (IQ/OQ/PQ), test automation scripting, CI/CD integration, root cause analysis, regulatory compliance (21 CFR Part 11)
Preferred skills
3DExperience platform architecture knowledge, automated/controlled systems validation
Technologies
3DEXPERIENCE, CI/CD tools, bug tracking tools
Responsibilities
Develop and maintain test plans for 3DExperience modules; Execute various QA testing types; Develop validation documentation (Plans, Protocols, Reports); Contribute to test automation and framework maintenance; Analyze test results and assist in root cause analysis; Collaborate with cross-functional teams to drive validation activities; Ensure validation strategies meet regulatory requirements.
Seniority
Mid-Senior (5-9 years experience)
