Sterilization Manager

Harry Walsh Associates Ltd

Tipperary

Sterility Assurance Lead role available with a leading Medical Device manufacturer . This role will be SME on Sterilization processes ie. EO, E Beam, radiation. Will manage a team of 3 Engineers in the execution of sterilization validation/revalidation, new product qualification, troubleshooting sterilization issue. Responsibilities. Leads team that conduct sterilization qualification for new products and/or changes to existing products. Leads team that performs sterilization validation for radiation sterilized products including dose setting and quarterly dose audits. Leads team that performs sterilization validation for ethylene oxide sterilized products including new product qualification, annual revalidations, residual EO studies, and D-value studies. Leads team that provides product development and Operations teams sterilization Subject Matter Expert support. Leads team that assist in Supplier Quality audits of contract sterilization facilities and third party manufacturers. Leads team that conducts dose audit failure investigations. Leads team that conducts Ethylene Oxide Biological indicator sterility positive investigation. Experience: Bachelor`s degree plus 9+ years of related work experience with a strong understanding of specified functional area Advanced degree preferred. Substantial knowledge of a Radiation and or Ethylene Oxide or other sterilization modality. This job originally appeared on RecruitIreland.com.

2151 days ago