Director, Validation

As a member of the Validation organization, the Validation Director will lead pharmaceutical and medical device validation operations and staff across all PCI sites. The scope of responsibility encompasses all planning and implementation of drug and medical device overall validation activities, including computer systems, in a CMO aseptic fill finish environment and ensure the proper validation of all equipment and processes. The Validation Director will also schedule the appropriate resources for assistance with validation, to meet the established production schedule, vendor/contract activities in the cleanrooms, maintain a state of control within the cleanroom environment, and support facilities and other operations, development and maintenance of validation program documents including SOPs, Validation Project (VPP) and Validation Master (VMP) Plans. This individual should be able to manage tasks and responsibilities with minimal guidance and demonstrate outstanding multi-tasking, problem solving and communication skills, in a dynamic and challenging contract manufacturing environment.