Senior Microbiologist

Elusav Recruitment Ltd.; Ireland; Sur place; EUR 65 000 - 90 000; Plein temps

Résumé du poste

Elusav Recruitment Ltd. in South Dublin invites an experienced Microbiologist to lead the microbiology, cleanroom and sterilisation activities within a global medical devices site. This is a key hire with full ownership across microbiology and related manufacturing processes.

You will work on regulatory compliance, GLP, and quality systems, mentoring Microbiology Technicians and ensuring audit readiness in a high-impact, highly regulated environment.

Qualifications

• Degree in Science with Microbiology specialization.
• Minimum 5 years' experience in medical devices/pharma/biotech.
• Expertise in GLP, cleanroom operations, and environmental monitoring.
• Experience with process validation and sterilization compliance.

Responsabilités

• Maintain knowledge of regulatory requirements for microbiology, sterilization, and cleanroom controls.
• Provide technical oversight for ETO sterilization and related requalification.
• Support technicians in microbiological testing and environmental monitoring.
• Set microbiological and sterilization quality standards across the site.
• Lead root cause investigations of microbiology or sterilization non-conformances.
• Ensure audit readiness and compliance with quality systems.

Connaissances

Glp principles

Cleanroom operations

Environmental monitoring

Sterilization processes

Regulatory knowledge

Formation

Science degree with Microbiology

Outils

ETO sterilization processes

ISO 11135 compliance

Description du poste

Elusav Recruitment have a great opportunity for an experienced Microbiologist with a global medical devices company based in South Dublin, supporting a brand new manufacturing area on site. This is a key hire — you'd be the lead microbiology SME within the suite, with full ownership across microbiology, cleanroom, and sterilisation activities.

The company offers an excellent benefits package, and given the size of the site, there's a strong opportunity to gain broad exposure across multiple areas, with real autonomy and learning opportunities. Really interesting role as the products are used in the administration of oncology treatments, so it's a high-impact, highly regulated environment.

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 behaviour, 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.

Requirements:

• 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: 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.