Validation Engineer
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Job Location:
Bloomington, IN - USA
Monthly Salary:
Not Disclosed
Posted on:
6 days ago
Vacancies:
1 Vacancy
Department:
Job Summary
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 meetregulatory/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
Bachelors Degree in Mechanical Engineering Mechanical EngineeringTechnology or Biomedical Engineering or related field; or experience ofsuch kind and amount as to provide a comparable background
Minimum 3 years experience in medical device process development orprocess validation
Experience recording and analyzing data and clearly expressingconclusions and recommendation in writing
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
