I'm currently working an excellent role with one of our Medical Device clients in Dun Laoghaire. This is an 18 month contract role as part of an exciting new project. Ideally, you will have experience in EO Sterilisation processes.
Job Purpose:
Responsible for ensuring that products manufactured at the Dun Laoghaire site comply with all microbiological, ETO sterilization, GLP, and cleanroom requirements.
This role provides technical microbiology and sterilization expertise, ensures adherence to regulatory and company standards, and maintains the site in a state of inspection readiness throughout the contract period.
Responsibilities:
Maintain 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 processes; product adoption, full/ reduce sterilization requalification; GLP-compliant laboratory practices; and cleanroom behavior, controls, and environmental monitoring.
Support 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 integrity expectations.
Perform any other duties as reasonably required by management during the contract period.
Educational Requirements and Relevant Experience:
Degree in Science or a related Quality discipline, specializing in Microbiology.
Minimum 5 years’ experience in medical devices, pharmaceutical, or biotech sectors.
Demonstrated expertise in: ETO sterilization (cycle review, dose audits, standards compliance); GLP principles and laboratory governance; and cleanroom operations and environmental monitoring.
Experience with process validation, sterilization validation, and cleanroom compliance.
Radiation or sterilization experience (ISO 11135 / ISO 11137) advantageous.
Knowledge, Skills and Abilities:
Excellent 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 supervision.
