Validation Engineer

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.

• 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. These activities include, but not limited to, the development of product/process, process changes, transfer for process, negative
quality trends, change in product design, change in application of process, process technical review, and reviewing out-of-control states of process via ongoing statistical process controls.
• Characterization of processes and their outputs/acceptance criteria
• Written preparation of applicable validation reports that meet regulatory/company standards
• Review of Process Failure Mode and Effects Analysis, updating Product Specification sheets, performing database queries, meetings, reviewing quality department feedback, CAPA activities.
• Project management
• Maintain accurate and timely reports and records, contemplate time and changes that occur over time.

• Bachelor's Degree in Mechanical Engineering, Mechanical Engineering Technology or Biomedical Engineering, or related field.
• Minimum 3 years experience in medical device process development or process validation, risk management and work related to polymer processing. 

• Experience recording and analyzing data and clearly expressing conclusions and  recommendation in writing, validation certification, problem solving, statistical analysis, project management.