Job Description
Company Microbiologist - South Dublin
Ref No: AM18569
County Dublin, Republic of Ireland
Competitive salary
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.
Interested applicants should have:
• 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.