Validation Specialist

Overview

Lead validation activities for automated systems in regulated environments. Develop and execute validation protocols in compliance with industry standards.

Responsibilities

• Develop and execute validation protocols for automated systems
• Ensure compliance with regulatory requirements (FDA, GMP, etc.)
• Lead risk assessments and manage validation documentation
• Collaborate with engineering and quality assurance teams
• Perform qualification testing of automation systems
• Support audit activities and regulatory inspections
• Maintain validation documentation systems
• Train personnel on validation procedures and requirements

Requirements

• Bachelor's degree in Engineering, Computer Science, or related field
• 5+ years experience in validation within regulated industries
• Knowledge of GMP, FDA, and other regulatory requirements
• Experience with test execution and documentation
• Strong attention to detail and documentation skills
• Understanding of automated manufacturing systems
• Excellent project management abilities
• Experience in pharmaceutical, biotech, or medical device industries preferred

Benefits