Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards and other in.
Experience working with Documentum or Maximo a plus.
Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
Strong verbal and written communication skills; excellent organizational and time utilization skills.
Ability to work independently and within project teams.
Industry experience related to cGMP drug manufacturing, validation, and chemical process design.
Strong computer knowledge including Microsoft Office products.
