Process Development Scientist

Process Development Scientist to validate and document processes in a highly regulated environment for pharmaceutical/biotech processes.Will operate specialized laboratory equipment and computers as appropriate.Interpret and apply GLPs and GMPs.Apply a science-based approach to production.Development and Execution of Processes/Equipment CharacterizationEstablish Testing StrategiesDesign / Development of Characterization ProtocolsTechnical Reports DevelopmentValidations, and technical reports to support SATs executions, document generation and challenge validations strategies.Risk assessments and QRAES knowledge, to support risk assessments activities.Develop solutions to routine technical problems of limited scope.Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.Requisitos:Doctorate or Master's degree and 5 years of Scientific experience orBachelor's degree and 6 years of Scientific experienceBasic technical report and validation protocol writingBilingual (Spanish/English); verbal and writtenFlexibility to work off-hours