Role – Microbiology & Sterilisation Specialist (12-Month Contract)
Location – South County Dublin/Wicklow
Salary – €65,000 (pro rata)

Working week – 8.30 to 5 pm. Monday to Friday

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.

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:
  • Ethylene Oxide (EtO) sterilisation processes
  • 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.
• Strong expertise in:
  • 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.

Skills & Competencies

• 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.

If you are interested in this role, send your CV to elaine@stormrecruitment.ie to apply.