PLM Software Quality & Validation Engineer

About the role

Amgen is looking for a PLM Software Quality & Validation Engineer who works closely with cross-functional teams to ensure that PLM solutions follow the required validation processes, documentation and standards, and align with Amgen's standard operating procedures, policies and guidelines. The goal is to help engineering teams build and deploy compliant products.

Key responsibilities

• Work in web applications and take part in functional, system, stress, performance, integration, regression and beta testing.
• Develop and maintain test plans for 3DEXPERIENCE platform modules and applications, and take part in release planning and test effort estimation.
• Test in an Agile environment, analyse and communicate test results to the team and manager.
• Write validation documentation such as Validation Plans, IQ/OQ protocols and Validation Reports, and ensure validation strategies meet regulatory requirements.
• Assist with UAT, test data preparation and work instruction development, and contribute to test automation scripting, framework maintenance and CI/CD integration.
• Implement automated test suites, analyse results, and help with root cause analysis of failures.
• Document bugs in a tracking tool, record deviations, change control and non-conformance, and suggest process improvements.
• Collaborate with quality assurance, system owners, business owners, RunOps, engineering and platform teams, and work with the product teams and Dassault on issue resolution.

Required profile

• Master's or Bachelor's degree and 5 to 9 years of experience in software quality and GMP validation.
• Experience in QA testing on the 3DEXPERIENCE platform or similar PLM/enterprise software.
• Experience in validation within a GMP-regulated environment (pharmaceutical, biotech, medical devices).
• Experience developing, executing and analysing QA and test automation.
• Good-to-have: understanding of 3DEXPERIENCE architecture and modules, and experience with 21 CFR Part 11 validation.

Required skills

• Validation protocols (IQ, OQ, PQ) and related documentation.
• Computer system validation and software validation.
• Test automation and CI/CD integration.
• Strong analytical, problem-solving, communication and teamwork skills.

What we offer

• Base salary plus competitive Total Rewards Plans aligned with local industry standards.
• Support for professional and personal growth and well-being.