Validation Engineer

What You’ll Do

• Lead and support equipment, process, and system validations across manufacturing operations
• Develop and execute validation protocols and performance testing for new and existing systems
• Analyze validation data to ensure compliance with specifications and regulatory requirements
• Maintain calibration systems, validation documentation, and equipment databases
• Partner cross-functionally with Quality, Engineering, and Manufacturing teams
• Support CAPA, nonconformance investigations, and root cause analysis
• Contribute to design controls, change management, and product development quality activities

• 5+ years of experience in Validation / Quality Engineering within a regulated industry
• Background in medical device or pharmaceutical environments
• Strong knowledge of FDA regulations, ISO 13485, cGMP, and QSR requirements
• Experience with process validation, test method validation, and calibration
• Familiarity with design controls, risk management (ISO 14971), and quality systems
• Strong analytical, documentation, and cross-functional communication skills

• Direct impact on product quality, compliance, and patient safety
• Exposure to end-to-end validation and quality systems
• Opportunity to work in a regulated, high-growth environment
• Strong career growth within Quality & Regulatory functions

Compensation: $80-100k base

Benefits: Medical, dental, vision, paid sick leave where applicable by state law

Equal Opportunity Employer/Veterans/Disabled