Senior Microbiology Analyst - Cleanroom & Sterilisation

CLS - Complete Laboratory Solutions

Limerick

On-site

EUR 60,000 - 75,000

Full time

2 days ago

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Job summary

Complete Laboratory Solutions (CLS) is seeking a Senior Microbiology Analyst to manage the microbiological control programme for a site with five ISO Class 8 cleanrooms. You will be the microbiology and sterilisation contact, working daily with the Senior Microbiologist.

Responsibilities include environmental monitoring, product testing, sterilisation support, quality system activities, and investigations. Strong knowledge of ISO standards and a background in regulated medical device

Qualifications

Degree in Microbiology or related discipline.
Hands-on cleanroom microbiology and environmental monitoring experience in regulated settings.
Experience with deviations, non-conformances, CAPAs and OOS investigations.
Familiarity with ISO 13485, 17141, 14644-1/3, 11737-1/3 or similar standards.

Responsibilities

Manage microbiology control programme for five ISO Class 8 cleanrooms.
Oversee product bioburden, endotoxin testing and water testing.
Coordinate sterilisation support including EtO requalifications.
Lead investigations and drive corrective actions with cross-functional teams.
Prepare and review reports: monthly microbiology reports and annual environmental reports.