* Generating, executing, and reviewing protocols for controlled temperature units and packaging equipment. .
* Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.
* Identify deviations from established product or process standards and provide recommendations for resolving deviations.
* Prepare, maintain, or review validation and compliance documentation, such as engineering change controls, schematics, or protocols.
* Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
*Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.
* Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production
* Summarize Protocol execution and results for the IQ/OQ/PQ Summary Report
* Perform Document/SOP Writing
* Coordinate Validation Projects and ensure project timelines
* Manage and maintain all validation test equipment.
*Manage and maintain all Refrigerators, Freezers (CTUs) and Walk-In Cold Rooms/ Warehouse Storage Facilities within a proper validated state according to FCS standards.