Principal Sterilization

Preferred Requirements New Products knowledge Sterilization Qualifications Protocols Validation Documentation Remote with hours compatibility variables Fully Bilingual Job Description Responsible for developing/modifying, qualifying and implementing Ethylene Oxide sterilization processes with contract sterilizers in accordance with ISO 11135 and applicable international standards. Managing communications with contract sterilizers and/or laboratories in support of qualification of sterilization processes and associated microbiological/chemical methods (i.e. ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7). Interprets and evaluates the analyses against established specifications and recommends and implements corrective action where necessary. Support assessment and/or implementation of environmental monitoring methods for cleanroom manufacturing of a terminally sterilized device in accordance with ISO 14644 series standards, EN 17141 and applicable standards. May also be involved in establishing requirements for the transfer of methodology from R&D. Demonstrated Experience in Ethylene Oxide Sterilization Process Validations per ISO 11135. Knowledge in supporting microbiological and chemical methods to support EO sterilization per applicable standards: ISO 11737-1, ISO 11737-2, ISO 11737-3, ANSI/AAMI ST72, ISO 10993-7. Knowledge of environmental monitoring requirements for manufacturing of a terminally sterilized device per ISO 14644 series standards, EN 17141. *Weil Group is proud to be an Equal Employment Opportunity Employer.* #J-18808-Ljbffr