GxP Test Lead-67507

=== POSTING ==

QA Validation Engineer -GxP Boca Raton, Florida (Onsite) Job Description: We are seeking a Senior QA Validation Engineer with 10+ years of software testing experience, including 8+ years in regulated environments such as Life Sciences or Pharmaceuticals. The ideal candidate will have strong expertise in GxP compliance and Computer System Validation (CSV) and extensive experience testing custom-built and mobile applications. Key Responsibilities:

• Lead and execute functional testing for custom-built web and mobile applications in regulated environments
• Ensure compliance with GxP, CSV, and regulatory standards
• Develop and maintain validation documentation (Test Plans, IQ/OQ/PQ, RTM, etc.)
• Apply risk-based testing methodologies aligned with regulatory expectations
• Collaborate with cross-functional teams in Agile, Waterfall, or hybrid SDLC environments
• Manage defects and test cycles using tools like JIRA, HP ALM, or similar test management systems
• Support audit readiness and compliance documentation

Required Qualifications:

• 10+ years of QA/testing experience
• 8+ years in Life Sciences/Pharma regulated environments
• Strong knowledge of GxP and Computer System Validation (CSV)
• Experience in functional and mobile testing
• Deep understanding of STLC and SDLC methodologies
• Hands-on experience with JIRA, HP ALM, or similar QA tools
• Experience with risk-based validation and testing strategies

*ALL successful candidates for this position are required to work directly for PRIMUS. No agencies please only W2**

For immediate consideration, please contact:

Rachna Gaur
PRIMUS Global Services
Phone:
Email: