Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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:
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.
Requirements:
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.