Contractor-Validation Engineer

The Validation Engineer at Cook Polymer Technology is responsible for performing and documenting validations of medical device component manufacturing processes. This position requires project management and leadership skills to help coordinate efforts between multiple teams.  The validation engineer’s work will support process risk management, sustaining/ continuous improvement efforts, manufacturing changes, and process and product development.

• Validate medical device component manufacturing processes as assigned.
• Identify installation qualification requirements, including equipment/ tooling, calibration, documentation, and training requirements.
• Characterize processes and their key process parameters for operational qualifications.
• Identify the key process outputs and acceptance criteria for performance qualifications.
• Arrange and document verification testing.
• Support and perform Test Method Validation.
• Write excellent validation reports that meet regulatory/company standards.

• Bachelors Degree in Chemical Engineering, Materials Engineering, 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 regulated manufacturing process development or process validation.
• Proficient in MS Office applications, especially Excel and Word.