Job Title - Microbiology & Sterilisation Specialist (12-Month Contract):
Location - South County Dublin/Wicklow
Salary - €65,000
Working week - 8.30 to 5 pm. Monday to Friday
Essential - Min 5 years experience in Microbiology in a regulated environment
Overview
Our Client is seeking an experienced Microbiology & Sterilisation Specialist to join their team on a 12-month contract at the South Dublin/Wicklow site. This is a key technical role responsible for ensuring all products meet the highest microbiological, sterilisation, and cleanroom compliance standards within a regulated environment.
Job Purpose
You will provide expert oversight in microbiology and sterilisation processes, ensuring compliance with regulatory requirements, internal quality systems, and maintaining continuous inspection readiness. You will be the single point of contact for Microbiology matters on the team with autonomy and sole responsibility for all work. You must have experience in taking the lead and ownership of projects.
Key Responsibilities
Maintain up-to-date knowledge of global regulatory requirements in microbiology, sterilisation (including ISO 11135 & ISO 10993), and cleanroom operations (ISO 14644).
Provide technical expertise in:
Sterilisation validation and re-qualification
GLP laboratory practices
Cleanroom behaviour, controls, and environmental monitoring
Support Microbiology Technicians in testing, monitoring, and sterilisation activities.
Define and enforce microbiological and sterilisation quality standards across the site.
Ensure compliance with internal procedures and global Quality System regulations.
Review sterilisation cycles and microbiological data; approve product release.
Lead or support investigations into non-conformances, including root cause analysis and CAPA.
Act as the site Subject Matter Expert (SME) for microbiology and sterilisation.
Maintain audit and inspection readiness at all times (internal, regulatory, Notified Body).
Ensure laboratory safety, equipment readiness, and data integrity compliance.
Requirements
Degree in Science or a related discipline, with a focus on Microbiology.
Minimum 5 years’ experience in medical devices, pharmaceutical, or biotech industries.
GLP and laboratory governance
Cleanroom operations and environmental monitoring
Experience in process validation and cleanroom compliance.
Knowledge of Ethylene Oxide sterilisation (ISO 11135) is highly desirable.
Strong knowledge of ISO 13485 and FDA QSR/QMSR regulations.
Excellent problem-solving and analytical skills, particularly in investigations and CAPA.
Ability to work cross-functionally in a regulated environment.
Strong communication and interpersonal skills.
High level of proficiency in Microsoft Office.
Capable of managing complex technical responsibilities independently.
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