I'm currently working an excellent role with one of our Medical Device clients in Dun Laoghaire. This is an 18 month fixed term contract role.Job PurposeResponsible for ensuring that products manufactured at the Dun Laoghaire site complywith all microbiological, ETO sterilization, GLP, and cleanroom requirements.This role provides technical microbiology and sterilization expertise, ensures adherence toregulatory and company standards, and maintains the site in a stateof inspection readiness throughout the contract period.ResponsibilitiesMaintain up-to-date knowledge of all relevant international regulatory requirements related to microbiology, sterilization (including ISO 11135 and ISO 10993), and cleanroom controls applicable to Dun Laoghaire products.Maintain up to date knowledge of all relevant international regulatory requirements related to cleanroom operation (including ISO 14644 and ).Provide daily technical oversight and subject matter expertise for: ETO sterilization compliant laboratory practices; and cleanroom behavior, controls, andSupport Microbiology Technicians in the execution of microbiological testing, environmental monitoring, and sterilization activities.Set appropriate microbiological and sterilization quality standards for products and ensure consistent application across the site.Ensure full compliance with internal sterilization procedures, cleanroom requirements, GLP expectations, and global Quality System regulations.Review sterilization cycles, microbiological data, and processed product lots; approve lots for release in accordance with quality standards.Lead or support root cause investigations involving microbiological or sterilization-related non-conformances.Act as microbiological and sterilization technical specialist for the Dun Laoghaire site and collaborate with relevant technical specialist groups.Support the site in always maintaining audit and inspection readiness (internal, external, Notified Body, and regulatory).Maintain laboratory safety, equipment readiness, and compliance with data integrityPerform any other duties as reasonably required by management during the contract period.Educational Requirements and Relevant ExperienceDegree in Science or a related Quality discipline, specializing in Microbiology.Minimum 5 years’ experience in medical devices, pharmaceutical, or biotech sectors.Demonstrated expertise in: GLP principles and laboratory governance; cleanroom operations and environmental monitoring.Experience with process validation and cleanroom compliance.Terminal Sterilization/Ethylene Oxide Sterilization and ISO 11135 advantageous.Knowledge, Skills and AbilitiesExcellent interpersonal, communication, and team-building skills.Proven ability to work within cross-functional teams in a regulated environment.Strong understanding of ISO 13485, FDA QSR/QMSR, and sterilization standards.Strong analytical and problem-solving skills with experience in investigations and CAPA.High level of computer literacy, including Microsoft Office applications.Ability to manage complex technical activities independently with minimal
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