What are the responsibilities and job description for the Validation Engineer position at Katalyst CRO?
Job Summary
Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities.
Responsibilities
Seeking a Facilities Validation Specialist who will be responsible for working across two state-of-the-art medical device facilities. They will have a long-term contract position with significant project ownership an opportunity to work with advanced cleanroom environments and warehouse facilities.
Responsibilities
- Lead facility commissioning activities across multiple sites.
- Conduct temperature and humidity mapping studies.
- Perform cleanroom validation for Class 6, 7, and 8 environments.
- Execute validation protocols for Class 9 cleanroom facilities.
- Manage warehouse validation projects.
- Develop and review validation documentation.
- Coordinate with cross-functional teams to ensure compliance.
- Implement and maintain validation strategies.
- Monitor and report on validation activities.
- Troubleshoot and resolve validation-related issues.
- Bachelor's degree in engineering, Science, or related field preferred.
- 5 years of facilities validation experience in medical device or related regulated industry.
- Proven experience with cleanroom validation and environmental monitoring.
- Strong knowledge of GMP requirements and regulatory standards.
- Demonstrated ability to work independently with minimal supervision.
