The Quality Validation Specialist would be responsible for reviewing, participating and ensuring facilities, equipment, utilities are fully qualified and performing as designed. In the execution of this position the individual will support the validation program by writing, executing or providing oversight for detailed protocols and reports to document the validation of facility systems, equipment and utilities in compliance with the appropriate regulatory agency validation requirements.
This individual will also participate in communicating validation activities during audits by customers and regulatory authorities. The position requires performance with minimal supervision and the ability to identify validation requirements and analyze and resolve the unique situations presented in the commissioning and qualification of a sterile injectable facility.