Overview
The Company Microbiologist is accountable for ensuring that all products produced at the Dun Laoghaire 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 the Dun Laoghaire 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 Dun Laoghaire site
Act as microbiology and sterilization technical specialist and SME for the Dun Laoghaire 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 embecta technical specialist groups
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 time
Educational Requirements and Relevant Experience
Degree in Science or related Quality discipline specialising in Microbiology
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
Knowledge, Skills and Abilities
Excellent interpersonal, communication and team building skills
Must be computer literate with knowledge of Microsoft Office software an advantage
Experience in process validation, Sterilization and working in a clean room environment would be advantageous.
Thorough knowledge of sterilization and microbiology requirements for terminally sterilized medical devices including ISO *****, ISO *****, ISO *****, FDA and EUMDR requirements along with other relevant standards
Proven ability of working in a cross-functional team environment
Excellent interpersonal and communication skills and high level of computer literacy
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