Senior Microbiologist

Role overview

This contract position is based onsite in South Dublin and is focused on safeguarding microbiological, sterilisation, GLP, and cleanroom compliance for site-manufactured products. The Senior Microbiologist will act as the technical authority for microbiology and sterilisation, helping the site remain fully prepared for inspections and audits throughout the assignment.

Key responsibilities

• Keep current with international regulations and standards covering microbiology, sterilisation, and cleanroom controls that apply to the site’s products.
• Stay updated on cleanroom operation standards, including ISO 14644 and related requirements.
• Provide day-to-day specialist guidance on ETO sterilisation, product adoption, full and reduced sterilisation requalification, GLP laboratory practices, and cleanroom conduct, control, and environmental monitoring.
• Assist Microbiology Technicians with microbiological testing, environmental monitoring, and sterilisation-related work.
• Establish suitable microbiological and sterilisation quality standards and ensure they are applied consistently across the site.
• Drive adherence to internal sterilisation procedures, cleanroom rules, GLP expectations, and global quality system requirements.
• Review sterilisation cycles, microbiological results, and processed product batches, and approve product release in line with quality standards.
• Lead or support root cause investigations linked to microbiological or sterilisation non-conformances.
• Serve as the site’s microbiology and sterilisation subject matter expert and work with relevant specialist groups.
• Help maintain continuous readiness for internal, external, Notified Body, and regulatory audits and inspections.
• Ensure laboratory safety, equipment availability, and compliance with data integrity expectations.
• Carry out any additional tasks reasonably assigned by management during the contract term.

Experience and qualifications

• A degree in Science or another relevant Quality discipline with a specialism in Microbiology.
• At least 5 years of experience in the medical devices, pharmaceutical, or biotech sector.
• Strong hands-on knowledge of sterilisation cycle review, dose audits, standards compliance, GLP principles, laboratory governance, cleanroom operations, and environmental monitoring.
• Experience in process validation, sterilisation validation, and cleanroom compliance.
• Exposure to radiation or sterilisation standards such as ISO 11135 or ISO 11137 would be an advantage.

Skills and competencies

• Strong communication, collaboration, and relationship-building skills.
• Comfort working with cross-functional teams in a regulated environment.
• Solid understanding of ISO 13485, FDA QSR/QMSR, and sterilisation standards.
• Good analytical thinking and troubleshooting ability, with experience in investigations and CAPA.
• Confident using computers and Microsoft Office tools.
• Ability to independently manage complex technical work with limited supervision.

Additional information

This role is contract-based and onsite. The position is intended to support the site for the full contract period while maintaining microbiological control, sterilisation integrity, and inspection readiness.