Director of Validation

This position reports directly to the V.P. of Quality and is ideally suited for a professional with strong background in facility/utility/equipment/CSV validation. This is a great opportunity to lead and evolve this function within a CDMO business, to support a broad portfolio and advance the manufacturing capabilities to deliver products to the client projects – that transform the lives of patients.

· Responsible for validation programs in support of CGMP manufacturing of clinical trial materials and commercial products

· Responsible for facility, utility, and equipment qualification programs

· Responsible for QA role of assay validation

· Responsible for computer system validation (CSV)

· Responsible for process and cleaning validation

· Maintain and update facility wide validation master plan, and individual master plans for various systems.

· Supervisor, mentor validation staff with the goal of building a sustaining validation team