Overview

The Validation Engineer at Cook Polymer Technology is responsible for providing technical support for the day-to-day production activities, engineering activities, and quality activities. This position requires project management, team management, and leadership skills to help coordinate efforts in maintaining the validated state of the processes. The engineer will help support and facilitate quality improvement efforts, manufacturing changes, process and product development, process risk management, and execution of validation activities.

Responsibilities

• Develop validation and revalidation protocols, execute protocols, and summarize activities. Execution of protocols typically requires interacting with processing systems, software systems, people/teams, and performing data analysis.
• Support production, engineering teams, development teams, quality teams, and management activities via validation and revalidation projects.
• Characterization of processes and their outputs/acceptance criteria
• Written preparation of applicable validation reports that meet regulatory/company standards
• Verification testing
• Project management
• Review of Process Failure Mode and Effects Analysis, updating Product Specification sheets, performing database queries, meetings, reviewing quality department feedback, CAPA activities.

Qualifications

• Bachelor's Degree in Mechanical Engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field; or experience of such kind and amount as to provide a comparable background
• Minimum 3 years experience in medical device process development or process validation

• Experience recording and analyzing data and clearly expressing conclusions and recommendation in writing