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 What We’re Looking For 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 Why This Role? 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 #J-18808-Ljbffr