Software Quality & Vadilation Engineer

ABOUT AMGEN

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.

ABOUT THE ROLE

Role Description:

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.

Roles & Responsibilities:

• 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.

• Develop and maintain comprehensive test plans for 3DExperience platform modules and application

• Involve actively in release planning and estimate test efforts

• Test in an Agile development environment, analyze and communicate test results to team and manager

• Develop validation documentation such as Validation Plans, Validation Protocols (IQ/OQ), and Validation Reports.

• Ensure validation strategies meet regulatory requirements and company standards.

• Stay updated on relevant changes to Amgen s SOPs and ensure validation practices are aligned with evolving standards.

• Assist with UAT, test data preparation and developing work instructions.

• Contribute to test automation scripting, framework maintenance, and CI/CD integration.

• 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.

• Ensure proper documentation of validation activities, including deviations, change control, and non-conformance management.

• Identify opportunities for process improvements in validation activities.

• Stay current on new technologies, validation trends, and industry best practices to improve validation efficiencies.

• Collaborate and communicate effectively with the product teams and Dassault to pursue issue resolution.

Functional Skills:

Must-Have Skills:

• 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

• Proficiency in developing and executing validation protocols (IQ, OQ, PQ), reports, and related documentation.

• Experience with computer system validation and software validation.

• Strong problem-solving and analytical skills.

Good-to-Have Skills:

• Understanding of 3DExperience platform architecture, modules, and integration points is highly desirable

• Experience with automated and computer-controlled systems validation (21 CFR Part 11)

Education and Professional Certifications

• Master s / Bachelors degree with 5 - 8 years of experience in Software Quality and GxP Validation OR

Soft Skills:

• Excellent analytical and troubleshooting skills.

• Strong verbal and written communication skills

• Ability to work effectively with global, virtual teams

• High degree of initiative and self-motivation.

• Ability to manage multiple priorities successfully.

• Team-oriented, with a focus on achieving team goals.

• Ability to learn quickly, be organized and detail oriented.

• Strong presentation and public speaking skills.

EQUAL OPPORTUNITY STATEMENT