Senior Quality Engineering Specialist

Senior Quality Engineering Specialist at a gene-editing biotech company provides operational support for GxP-regulated software, equipment, and vendor oversight. The role executes qualification activities, maintains compliance records, and conducts risk-based assessments of software vendors and suppliers.

Responsibilities

• Draft, execute, and review software assurance test scripts for GxP systems
• Conduct risk-based assessments of software vendors per FDA guidance
• Support quality oversight of computerized systems including AI-enabled tools
• Maintain accurate records and coordinate scheduled qualification and maintenance activities
• Evaluate equipment, material suppliers, and service providers for quality and reliability

Requirements

• Experience with GxP software systems and computerized system validation
• Knowledge of FDA guidance for software vendor assessment and risk evaluation
• Hands-on expertise in equipment qualification and preventive maintenance
• Ability to develop and execute test scripts based on specifications and requirements
• Strong understanding of regulatory compliance and inspection readiness protocols