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 11137, ISO 11737, ISO 14644, 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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