Senior Microbiology Analyst: Cleanroom & Sterilization Lead

CLS - Complete Laboratory Solutions; Limerick; On-site; EUR 70,000 - 95,000; Full time

Job summary

Complete Laboratory Solutions (CLS) in Ireland is seeking an experienced Microbiologist to manage the microbiological control programme for a site operating five ISO Class 8 cleanrooms. You will be the site's microbiology and sterilisation point of contact, working daily with the Senior Microbiologist.

The role covers environmental monitoring, product testing, sterilisation support, and quality system activities within a regulated medical device environment.

Qualifications

• Degree in Microbiology, Biological Sciences, or a related discipline.
• Hands-on experience in cleanroom microbiology and environmental monitoring within a medical device or similarly regulated environment.
• Working knowledge of ISO 13485, ISO 17141, ISO 14644-1, ISO 11737-1, ISO 11737-3 and related standards.
• Experience with Deviations, Non-Conformances (NCs), CAPAs, and OOS investigations.
• Experience with EtO sterilisation, requalification, and validation documentation (desirable).
• Familiarity with continuous improvement methodologies (A3, PDCA, DMAIC).
• Strong written communication skills and cross-functional collaboration.

Responsibilities

• Manage microbiological control for five ISO Class 8 cleanrooms, including product bioburden and endotoxin testing, non-viable particulate monitoring, environmental monitoring, and water testing.
• Oversee microbiology testing and prepare annual reports (Cleanroom Classification, Microbiology, Environmental Monitoring, Sterilisation).
• Lead investigations and implement corrective actions for out-of-spec results and deviations; review test results.
• Coordinate EtO sterilisation requalifications, validation protocols and reports; liaise with external labs and service providers.
• Support QMS updates, procedures, and change orders; develop training for monitoring and sampling.

Skills

Cleanroom microbiology

Environmental monitoring

Written communication

Cross-functional collaboration

Education

Degree in Microbiology or related discipline

Job description

Complete Laboratory Solutions (CLS) in Ireland is seeking an experienced Microbiologist to manage the microbiological control programme for a site operating five ISO Class 8 cleanrooms. You will be the site's microbiology and sterilisation point of contact, working daily with the Senior Microbiologist.

The role covers environmental monitoring, product testing, sterilisation support, and quality system activities within a regulated medical device environment.