Senior Microbiology Analyst - Cleanroom/Sterilization

Senior Microbiology Analyst - Cleanroom/Sterilization

Overview

CLS is currently going through an unprecedented and exciting period of growth and development and is looking for dedicated, solutions-driven team members with a flexible approach who want to be part of the company's continued success.

Founded in 1994, Complete Laboratory Solutions (CLS) is the highest accredited contract laboratory in Ireland, providing industry-leading sampling and analysis, as well as fully trained microbiology and analytical analysts on contract to clients in the food, environmental, medical device, biopharmaceutical, and pharmaceutical sectors.

We offer bespoke managed service solutions that give clients the option of having our expert team on-site at their own facility or outsourcing those services to us here at CLS.

The Role

We are 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.

Key Responsibilities

Cleanroom and Environmental Monitoring

• Manage microbiological control for five ISO Class 8 cleanrooms, including:

  • Product bioburden and endotoxin testing

  • Non-viable particulate monitoring

  • Environmental monitoring

  • Water testing

• Oversee microbiology testing and prepare Annual Cleanroom Classification Reports.

• Compile and review:

  • Monthly Microbiology Reports

  • Annual Environmental Monitoring Reports

  • Annual Sterilisation Reports

• Conduct and review environmental and water risk assessments.

• Liaise with service providers to ensure testing is completed accurately and on schedule.

Sterilisation Support

• Support annual EtO sterilisation requalifications and trial studies, including:

  • Dunnage reviews

  • Validation protocol writing and review

  • Validation report writing and review

• Coordinate residual, sterility, and B&F testing, and review and approve results.

• Review and release sterilisation loads during process deviations, ensuring timely and compliant product release.

Quality Systems and Investigations

• Complete microbiology and sterilisation-related:

  • Deviations

  • Non-conformances (NCs)

  • CAPAs

  • Supplier Corrective Actions (SCAs)

• Act as the Microbiology representative for investigations, quality non-conformances, and unexpected cleanroom issues, leading the response within the cleanroom and in site discussions.

• Lead investigations and implement corrective actions for Out of Specification (OOS) results.

• Review and approve microbiological test results.

• Complete microbiology assessments for:

  • Critical Systems Work Orders (CSWOs)

  • Cleanroom Equipment Installation Forms

• Evaluate supplier change notifications and complete microbiology and sterilisation impact assessments.

• Complete bioburden test method validations with an external contract laboratory.

• Support the Senior Microbiologist with Quality Management System (QMS) updates, including procedure revisions and change orders.

• Document and escalate customer complaints and deviations where appropriate.

Continuous Improvement and People Development

• Lead continuous improvement initiatives using:

  • A3

  • PDCA

  • DMAIC

• Collaborate with cross-functional teams and suppliers to drive quality improvements.

• Develop and deliver training in non-viable particulate monitoring and water sampling.

• Mentor and provide technical guidance to junior microbiology analysts.

Requirements

• 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

  • Other relevant industry standards

• Experience with:

  • Deviations

  • Non-conformances (NCs)

  • CAPAs

  • OOS investigations

• Experience with EtO sterilisation, requalification, and validation documentation (desirable).

• Familiarity with continuous improvement methodologies, including A3, PDCA, and DMAIC.

• Strong written communication skills and the ability to work effectively across functions and with external suppliers.

Diversity, Equity & Inclusion

Complete Laboratory Solutions (CLS) is committed to creating a diverse, inclusive, and equal workplace where everyone is treated with respect and given the opportunity to succeed.

We are proud to be an Equal Opportunities Employer and welcome applications from all qualified candidates regardless of background, gender, age, disability, ethnicity, religion, sexual orientation, or any other protected characteristic.