Sterilization Engineer

Job ***** Process Engineer/Gas Sterilization***** Cambridge, MA***** 12 MonthsResponsibilities include but are not limited *****a) support/ lead process development and commercialization of gas sterilization processes of combination productsb) coordinate/ lead manufacturing site requirements to support sterilization requirementsc) support the design control process and qualification of primary componentsd) support/ lead tech transfer projects for combination productse) support/ lead the development and operational improvements with key primary component suppliersg) support development of characterization methods for mechanical and physical properties of primary componentsh) support on-going deviation/ CAPA and change controli) support/ lead supplier/ raw materials sterility assurance assessmentsj) collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.k) drive and influence key opinion leaders by providing technical papers, presentations and attending key conferencesPreferred Qualificationsa) 3+ years in ethylene oxide or other gas sterilization processesb) 3+ years industry experience in sterility assurance of combination productsc) 3+ years in ethylene oxide, moist heat, and/ or vaporized hydrogen peroxide sterilizationd) Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures, or governmental regulationse) Strong problem-solving skillsf) Capability to advance multiple projects in a fast paced environmentg) Strong oral and written communication skills, decision making, presentation, and organization skills

Created: 2025-03-01