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Software Quality Assurance (QA) Test Engineer

Emedgene, an Illumina Company

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.
We seek a skilled PLM Software Quality & Validation Engineer to develop, execute and maintain the test scripts for 3DEXPERIENCE PLM platforms and custom-built solutions. This is a hands-on, growth-oriented position ideal for someone looking to deepen their skills in Functional testing and test automation on a cloud-based SaaS PLM software. As a key contributor, you will collaborate closely with cross-functional teams to ensure that the PLM solutions follow the required validation processes, documentation, and comply with Amgen’s standard operating procedures, policies, and guidelines. Your expertise will be instrumental in ensuring quality and adherence to required standards so that the engineering teams can build and deploy products that are compliant.
The ideal candidate will be accustomed to working in Web applications and should be actively involved in various types of testing such as Functional, System, Stress, Performance, Integration, Regression, and Beta.
Involve actively in release planning and estimate test efforts
Test in an Agile development environment, analyze and communicate test results to team and manager
Ensure validation strategies meet regulatory requirements and company standards.
Assist with UAT, test data preparation and developing work instructions.
Execute automated test suites across various modules in 3DEXPERIENCE.
Analyze test automation results, identify failures or inconsistencies, and assist in root cause analysis.
Collaborate with cross-functional teams, including quality assurance, system owners, business owners, RunOps, engineering, and platform teams to drive validation activities and meet project deadlines.
Work closely with manager on implementing automation strategies, document all bugs in a tracking tool, and always follow best QA practices
Ensure timely and effective completion of all validation activities in line with project objectives and schedules.
Experience in Quality Assurance (QA) testing with at least 3 years of experience specifically working on the 3DEXPERIENCE platform or similar PLM/enterprise software solutions.

  • 3+ years of experience in validation in a GxP-regulated environment (pharmaceutical, biotech, medical devices, etc.).
  • Experience in developing, executing and analyzing QA & Test Automation
  • Experience with computer system validation and software validation.
  • Experience with automated and computer-controlled systems validation (21 CFR Part 11)

Master’s / Bachelor's degree with 5 - 8 years of experience in Software Quality and GxP Validation OR

Ability to work effectively with global, virtual teams
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
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Vacancy posted more than 2 months ago
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