Company Microbiologist - South Dublin.
In this role you will be accountable for ensuring that all products produced at the site 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 this location
* Manage daily operations of the in-house microbiology laboratory, ensuring timely and accurate testing and equipment maintenance
* Setting of appropriate microbiological quality standards for all products, and implementation across the site in compliance with all sterilisation and environmental monitoring requirements
* Work 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 site.
* Act 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.
* Integrate and collaborate with appropriate technical specialist groups.
* Responsible for the validation and maintenance of environmental monitoring programs, and environmentally controlled manufacturing areas for the site.
Qualifications
* Degree in Science or a related Quality discipline specialising in Microbiology
* At least 8 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 advantageous
* Excellent interpersonal, communication and team building skills
* Must be computer literate
* Experience in process validation, sterilization and working in a cleanroom environment would be advantageous.
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