What are the responsibilities and job description for the Validation Specialist position at Katalyst CRO?
Summary
- Support cleaning validation activities, protocol execution, sampling, and documentation.
- Perform temperature mapping and requalification of controlled temperature units.
- Execute IQ/OQ/PQ, requalification, and periodic review for GMP equipment and utilities.
- Support commissioning, installation, and qualification of new or modified equipment.
- Assist with equipment troubleshooting alongside Engineering and Operations.
- Generate validation documentation following cGMP, GDP, and SOP requirements.
- Support validation lifecycle activities, change controls, investigations, and CAPAs.
- Participate in audit readiness and regulatory inspection support.
- Bachelor's degree in Engineering, Life Sciences, or related discipline required.
- 5 years of hands-on validation experience with GMP equipment and utilities.