Senior Microbiology Analyst: Cleanroom & Sterilization Lead

Complete Laboratory Solutions; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Complete Laboratory Solutions (CLS) is seeking a Senior Microbiology Analyst to oversee microbiology and sterilisation within five ISO Class 8 cleanrooms in a regulated medical device environment. You will manage environmental monitoring, product testing, and quality system activities, ensuring timely reporting and compliance.

You will coordinate sterilisation validation and requalification activities, lead investigations into deviations, and mentor junior staff while driving continuous

Qualifications

• Degree in Microbiology, Biological Sciences, or related discipline.
• Hands-on experience in cleanroom microbiology and environmental monitoring.
• Familiarity with ISO 13485, ISO 17141, ISO 14644-1, ISO 11737-1, ISO 11737-3.
• Experience with deviations, NCs, CAPAs, and OOS investigations.
• Experience with EtO sterilisation, requalification, and validation documentation (desirable).
• Strong written communication and cross-functional collaboration.

Responsibilities

• Manage microbiological control for five ISO Class 8 cleanrooms, including product bioburden testing and environmental monitoring.
• Oversee microbiology testing and prepare Annual Cleanroom Classification Reports.
• Compile Monthly Microbiology Reports and Annual Environmental Monitoring Reports.
• Coordinate EtO sterilisation requalifications, validation documentation, and testing.
• Lead investigations, deviations, NCs, CAPAs, and OOS responses with cross-functional teams.

Skills

Microbiology

Environmental monitoring

Quality systems

Documentation

Cross-functional collaboration

Education

Degree in Microbiology or related

Tools

EtO sterilisation

QMS documentation

Job description

Complete Laboratory Solutions (CLS) is seeking a Senior Microbiology Analyst to oversee microbiology and sterilisation within five ISO Class 8 cleanrooms in a regulated medical device environment. You will manage environmental monitoring, product testing, and quality system activities, ensuring timely reporting and compliance.

You will coordinate sterilisation validation and requalification activities, lead investigations into deviations, and mentor junior staff while driving continuous