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 / Bachelor's 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
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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