Senior Sterilization Engineer
hace 14 horas
Bath
Purpose • Develop and perform validations of gamma and ethylene oxide industrial sterilization, including performing quarterly gamma dose audits, bioburden monitoring, and annually reviewing the sterilization families for changes., • Develop and perform validations of cleanrooms, controlled areas, and utilities, including performing testing for validation and ongoing monitoring, and reviewing data to identify trends., • Responsible for monitoring, auditing, and reviewing sterilization and environmental monitoring processes and external testing laboratories, as well as associated procedures., • Review and resolve problems identified through environmental monitoring, industrial sterilization, sterilization monitoring, and endotoxin monitoring, including the documentation of out of specification reports and corrective and preventive actions (CAPA), and communication to operations staff regarding the risks and actions for resolution., • Review and assess changes impacting environmental monitoring and sterilization., • Bachelor of Science in Microbiology, Biology, or other scientific discipline, plus a minimum of five years’ work experience as a sterilization engineer or industrial microbiologist, or an equivalent combination of education and experience.