In this role, you will have experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred) in a BioPharma manufacturing environment.
In this role, you will write and execute validation protocols (DQ,IQ,OQ,PQ,RQ,PV) with little to no supervision as well as write comprehensive final reports containing thorough resolution of protocol discrepancies. Temperature mapping protocols are a primary focus. Provide on-site support for Genzyme and Sanofi sites. Provide PV support at CMOs.
In this role, the selected candidate will identify and manage asset reliability risks that could adversely affect Customer or business operations; assist the innovation engineers in controlling scope changes during design activities to achieve original customer requirements and documented additions.