Responsibilities

The MS&T Director, Validation Lead Steriles will set global procedures & templates for cleaning and process validation documentation and validation master plans, develop strategy for continued process verification (CPV) and annual monitoring batches, support sites during Regulatory inspections, provide expert technical support in aseptic manufacturing, validation, new technologies, and sterilization, continuously monitor GMP, EU, and FDA regulatory changes, partner with Engineering and IT to define the process validation/equipment/systems qualification interface, identify and drive opportunities for improvement in process effectiveness, product quality, and operating efficiency, own the Training Curriculum for cleaning and process validation and technologies, act as the Network SME for collaborating with the Local and global MSAT network, assure necessary benchmarking internally and externally, author and implement GOPs for assigned technology, and steward for Aseptic Network & New Product Launch.