Director of Validation

INCOG Biopharma Services seeks an experienced Director of Validation to lead validation function across GMP-certified sterile injectable drug product manufacturing and device assembly operations.

Requirements

• Develop and implement comprehensive validation strategies
• Lead the creation, approval, and execution of validation protocols and reports
• Maintain current knowledge of FDA regulations and industry standards
• Build, mentor, and manage a validation team
• Apply sound risk assessment principles and justify deviations
• Oversee process validation studies and ensure adequate data collection
• Direct IQ/OQ/PQ activities for new equipment installations and process modifications
• Lead cleaning validation programs across manufacturing suites and equipment
• Ensure all validation documentation is complete, accurate, and traceable
• Identify opportunities for validation process improvements and efficiency gains

Benefits

• Opportunity to work in a GMP-certified environment
• Collaborative and team-centered approach to doing business
• Chance to create systems from scratch and contribute to technical excellence