Validation Engineer

Validation Engineer

This position is responsible for writing, implementing, analyzing results and summarizing process validation activities in the areas of equipment installation, change management, and continuous lifecycle improvement. This individual will work through a validation backlog following the Quality System elements for process Validation including CAPAs and deviations. This position will work closely with members of the Quality Assurance, Manufacturing, and Engineering teams to develop process validation studies and projects to enhance the manufacturing processes to compliantly achieve organizational goals.

• Provide technical input to validation activities
• Represent process validation during equipment installations
• Support process validation Quality Systems
• Identify opportunities for personal and professional development, continuous improvements, and help deploy best practices
• Participate in regulatory agency inspections for Process Validation
• Serve as one of the main points of contact in communication to customers whose equipment and processes are being validated
• Responsible for updating site Project Management and aiding in schedule and cost forecasting of validation activities

• 3 or more years relevant experience in quality/validation
• Experience authoring and completing validation studies
• Understanding of cGMP requirements for validation documentation
• Demonstrated ability to collaborate with multiple functions to implement validation activities and incorporate validation results into routine operational practices
• Experience authoring and building process validation studies for commercial GMP manufacturing processes
• Experience troubleshooting/problem-solving and risk assessment/mitigation
• Working knowledge of the science and technology for the major unit operations associated with manufacturing operation is considered a plus
• Must be able to read, write and speak English