Validation/Quality Engineer in NJ - (Holmdel, NJ)

Position title: Validation/Quality Engineer Department: Quality Reports To: Manger, Quality/VP Quality The Quality Validation Engineer provides compliance support to the manufacturing plant and is responsible for implementing and maintaining equipment and utility validation programs. SUPERVISION RECEIVED Under the direct supervision of the Manager & VP of Quality DUTIES AND RESPONSIBILITIES Implementing and maintaining equipment and utility validation programs. Planning, executing, and documenting qualification studies that meet FDA and international regulatory agency requirements. Protocol generation or review, data analysis, report generation, and coordination of studies with Manufacturing and Quality Control Enter Non-Conformances, customer complaints and CAPAs into QCBD and lead investigations to close the documents to completion. Forward documents to customer as necessary