Validation Engineers

Manage specification, qualification, and validation requirements. Write and execute engineering change orders related to Corrective and Preventive Actions (CAPAs), changes in Critical to Quality (CTQs), release of aging reports, updates to design history files. Create, and update Failure Mode and Effect Analysis (DFMEA) for new implants and instruments. Perform validations (IQ, OQ, PQ) by creating and executing protocols. Perform GAP Analysis. Conduct Risk based verification for GxP (GMP, GCP, and GLP) systems and laboratory equipment. Conduct statistical analysis using Minitab. Master’s degree in Science, Technology, or Engineering (any) is required. Work location: Iselin, NJ and various unanticipated locations throughout the U.S.Send Resume to HR Dept., Shoolin, Inc., 120 Wood Avenue S, Suite 611, Iselin, NJ 08830.