Quality Validation Engineer

In this role you drive quality validation and regulatory compliance within a fast-paced, regulated manufacturing environment. You will lead CAPA investigations, support validation activities across equipment, processes, facilities, and computerized systems, and collaborate with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs. Your work ensures GMP/GxP alignment and continuous quality improvement at scale. This position offers meaningful impact in upholding high standards in aseptic and sterile manufacturing.

• Lead and manage CAPA investigations and activities
• Support validation activities for equipment, processes, facilities, and computerized systems
• Review documentation for quality systems and regulatory compliance
• Collaborate cross-functionally with Quality, Manufacturing, Engineering, Validation, and Regulatory Affairs
• Communicate complex information clearly to diverse stakeholders
• Manage multiple projects with aggressive timelines
• Maintain awareness of QSR, GxP, and FDA requirements

• Bachelor in Engineering
• Master in Engineering, Life Sciences, or related technical discipline (preferred)
• 6-9 years in pharmaceutical, biopharmaceutical, or similar regulated manufacturing environments
• Strong background in quality validation, quality systems, and regulatory compliance
• Experience leading CAPA investigations and activities
• Knowledge of QSR, GxP, FDA guidelines, and regulatory best practices
• Experience supporting validation activities (equipment, process, facility, computerized systems, documentation)
• Cross-functional collaboration experience
• Strong analytical, problem-solving, and attention to detail
• Excellent written and verbal communication
• Ability to manage multiple projects in a fast-paced environment
• Self-motivated and able to work independently in regulated settings

• Collaborative mindset
• Analytical thinking
• Attention to detail
• CAPA management
• Quality systems and regulatory compliance
• GxP / FDA knowledge