Senior Microbiology & Sterilisation Lead

Complete Laboratory Solutions; Limerick; On-site; EUR 60,000 - 90,000; Full time

Job summary

Complete Laboratory Solutions (CLS) seeks a Senior Microbiology Analyst to manage the microbiological control programme for five ISO Class 8 cleanrooms within a regulated medical device environment. You will serve as the microbiology and sterilisation contact, daily interacting with the Senior Microbiologist.

Responsibilities include environmental monitoring, product testing, sterilisation support, QMS activities, and audit-ready documentation across deviations, CAPAs, NCs, and OOS

Qualifications

• Degree in Microbiology or related life-science field.
• Hands-on experience in cleanroom microbiology and environmental monitoring in regulated environments.
• Familiarity with ISO 13485, ISO 17141, ISO 14644-1, ISO 11737-1, ISO 11737-3.

Responsibilities

• Manage microbiological control for five ISO Class 8 cleanrooms, including product bioburden and endotoxin testing.
• Coordinate sterilisation activities, residual and B&F testing, and review results.
• Lead deviations, NCs, CAPAs, and OOS investigations within Microbiology and Sterilisation.
• Prepare and review Annual/Monthly Microbiology and Environmental Monitoring Reports.
• Support QMS updates, procedure revisions, and change orders.

Skills

Cleanroom microbiology

Environmental monitoring

Sterilisation validation

OOS investigations

CAPAs

Deviations management

DMAIC

A3

Education

Degree in Microbiology

Job description

Complete Laboratory Solutions (CLS) seeks a Senior Microbiology Analyst to manage the microbiological control programme for five ISO Class 8 cleanrooms within a regulated medical device environment. You will serve as the microbiology and sterilisation contact, daily interacting with the Senior Microbiologist.

Responsibilities include environmental monitoring, product testing, sterilisation support, QMS activities, and audit-ready documentation across deviations, CAPAs, NCs, and OOS