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Validation Lead

Foster City, CA 94404 (Onsite)

FTE / CTH / Contract

Job/ Role Description:

• Proven leadership in testing, validation for medium to large system implementations, ensuring GxP compliance and quality delivery
• Extensive experience with Waterfall, Iterative, and Agile methodologies, guiding teams to successful project outcomes
• Proficient in Microsoft Office Suite (Project, Visio, Excel, PowerPoint) for project management and reporting
• Expertise in HP ALM for managing testing cycles, with broad technical knowledge of SaaS and Cloud systems in a GxP environment
• Strong understanding of 21 CFR Part 11, CSA guidelines, with 2+ years in computer systems validation and testing
• Flexibility to work different time zones, manage multiple projects, and travel as needed
  
  

Experience & Skills:

• Testing/Validation for System Implementations - Knowledge and prior experience in testing and validation for medium to large system implementations
• Experience in working with SaaS and Cloud systems in a GxP environment; Proficiency with HP ALM (Application Lifecycle Management)
• Thorough knowledge of GxP compliance, including 21 CFR Part 11 and CSA guidelines
• Methodologies: Experience with Waterfall, Iterative, and Agile methodologies
• BE / BCA / BSE in IT / Computer science / Biotech/Pharma with 10+ years of experience
• Ability to quickly adjust to new technologies, workflows, and environments