The Principal Validation Engineer is a Manufacturing Operations subject matter expert who actively collaborates with quality, regulatory, manufacturing, engineering and global I&D teams. Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also coordinate HEPA filter integrity/velocity testing and critical area airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant. Provides direction through direct or indirect supervision to validation team members and contractors as necessary. Responsible for project managing the implementation of projects from development groups to the plant manufacturing site. Responsible for providing technical guidance, implementing best practices and process improvements. The Principal Validation Engineer will also serve as a mentor and source of direction and support to other staff members within the group. The Principal Validation Engineer must also have outstanding verbal and written communication skills because this position interacts directly with multiple departments at the site, regional and global levels.