Excellent role as a Site Microbiologist for a Medical Device company based in South Dublin. This is a perm role with strong salary and benefits package. In this role you are responsible for ensuring that all products adhere to the specified microbiological and sterilization standards.Responsibilities:Responsible for maintaining up-to-date knowledge of all current relevant worldwide regulatory requirements that relate to products manufactured at the siteManage daily operations of the in-house microbiology laboratory, ensuring timely and accurate testing and equipment maintenanceSetting of appropriate microbiological quality standards for all products, and implementation across the site in compliance with all sterilisation and environmental monitoring requirementsWork with cross functional teams to support the radiation sterilization validation and routine monitoring for all products.Responsible for overseeing, approving and maintaining the Dose establishment, Bioburden testing, sterility testing, endotoxin testing and environmental monitoring programs for the site.Responsible for Risk assessments to support the sterility assurance activities on site.Responsible for determination of sterility assurance requirements for the site change control program.Responsible for all Sterility assurance and microbiology related out of specification investigations, non conformances and CAPA.Responsible for the sterilization product release program for all products from the siteAct as microbiology and sterilization technical specialist and SME for the site and participate in audits to represent the sterility assurance function.Act as an internal auditor supporting the site internal audit program.Responsible for the validation and maintenance of environmental monitoring programs, and environmentally controlled manufacturing areas for the site.Any other reasonable duties which may be required by management from time to timeEducational Requirements and Relevant Experience:Degree in Science or related Quality discipline specialising in Microbiology8+ years experience in a similar role, preferably in a medical devices, pharmaceutical or biologics manufacturing environment, experience supervising personnel and managing projects.Radiation and terminal sterilization experience would be advantageousThorough knowledge of sterilization and microbiology requirements for terminally sterilized medical devices including ISO 11137, ISO 11737, ISO 14644, FDA and EUMDR requirements along with other relevant standards.