About this role
The Validation Specialist II coordinates and implements various activities for compliant and effective support of the Secant Group Validation functions conforming to ISO 13485, internal, and customer requirements. Responsible for performing multiple validation disciplines including Software Validation (SV), Equipment Qualification (IOQ) and minor Software Programming. Also responsible for maintenance of the validated state of qualified utilities, equipment and software as required. Responsible for Performing Periodic Reviews of equipment and software per program requirements. The Validation Specialist II helps manage the Software Validation Programs for Solesis Sister Companies Charter Medical LLC and Polyzen LLC to ensure compliance with FDA and current industry software requirements.