Sr PLM Software Quality & Validation Engineer

Roles & Responsibilities:

• Work on validation and testing of web-based applications, specifically the 3DEXPERIENCE platform.
• Perform various types of testing such as functional, system, stress, performance, integration, regression, and beta testing.
• Develop and maintain detailed test plans for 3DEXPERIENCE modules and applications.
• Lead, mentor, and coach junior quality and validation engineers on test execution and documentation.
• Analyze test results, identify issues, and work collaboratively with product teams and Dassault Systemes for resolution.
• Prepare validation documentation including validation plans, IQ/OQ/PQ protocols, validation reports, deviations, change control, and non-conformance records in alignment with Computer System Validation (CSV) requirements.
• Ensure validation activities adhere to regulatory and organizational compliance standards (e.g., GMP, 21 CFR Part 11).
• Review and verify the quality, accuracy, and completeness of CSV documentation created by junior engineers.
• Develop and execute automated test suites across modules, including test automation scripting and integration with CI/CD frameworks.
• Conduct root cause analysis on test failures and work collaboratively to implement fixes.
• Collaborate with cross-functional stakeholders including QA, system owners, business leads, engineering, and platform teams to drive validation initiatives.
• Ensure all validation activities are completed on time, aligning with project deliverables and release schedules.
• Actively contribute to release planning, effort estimation, and workload prioritization.
• Identify and drive process improvement opportunities in validation activities.
• Stay current with emerging technologies, validation practices, and industry trends to enhance operational efficiency.

Basic Qualifications:

• Bachelor's, Master's, or Doctorate degree in Computer Science, Engineering, or related field.
• 8 to 13 years of experience in software quality and GMP validation.

Must-Have Skills:

• Manual and automated testing, 3DEXPERIENCE platform, enterprise software testing, Computer System Validation (CSV), GMP compliance, validation documentation (IQ, OQ, PQ), automated testing tools, CI/CD integration, root cause analysis, QA and test automation, software validation leadership.

Good-to-Have Skills:

• 3DEXPERIENCE platform architecture, PLM modules, 21 CFR Part 11 compliance, automated/computer-controlled systems validation.