Validation Engineer II

Validation Engineer IIResponsible for performing validation of equipment, utility systems, facilities, processes and/or automation systems by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements. Executes test plans according to approved procedures, collects samples, tabulates test results, and organizes data packages. Compiles and analyzes validation data, prepares reports and makes recommendations for changes and/or improvements. May also investigate and trouble-shoot problems which occur, and determine solutions. Coordinates and executes validation change control and preparation of draft protocols, reports and data tables. Maintains all documentation pertaining to validation. May assist in developing procedures and/or protocols. Coordinates contract personnel through completion of assignments. Works on cross-functional project teams as required. May provide day-to-day guidance and training to other validation technicians. Serves as an information resource to validation technicians, contractors and vendors. Resolves validation issues of moderate scope with limited direct supervision.