Senior Microbiologist

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; and fully trained micro 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 Senior Microbiologist will provide technical expertise in microbiological control, cleanroom monitoring, contamination control, and sterilisation within a regulated medical device environment. The role supports microbiology and sterilisation assessments, investigations, validation activities, risk assessments, and continuous improvement to ensure product quality and regulatory compliance.

• Lead microbiological control programs for multiple ISO Class 8 cleanrooms, encompassing product bioburden and endotoxin testing, non-viable particulate monitoring, environmental monitoring, and water testing.

• Complete microbiology risk assessments for critical systems work orders and cleanroom equipment installations.

• Maintain strong working knowledge of ISO 13485, ISO 17141, ISO 11737-1, ISO 14644-1, and other relevant regulatory standards.

• Complete bioburden test method validations in partnership with external contract laboratories.

• Support annual sterilisation (EtO) requalifications and trial studies, including dunnage review and validation protocol/report writing and review.

• Review and approve microbiological test results; lead investigations and implement corrective actions for out-of-specification (OOS) results.

• Manage microbiology and sterilisation-related deviations, non-conformances, CAPAs, and supplier corrective actions.

• Conduct and review environmental and water risk assessments.

• Compile and review monthly microbiology reports, annual environmental monitoring reports, and annual sterilisation reports.

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

• Coordinate residual, sterility, and bioburden/functionality (B&F) testing, and review and approve results.

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

• Oversee microbiology testing and author annual cleanroom classification reports.

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

• Lead continuous improvement initiatives using A3, PDCA, and DMAIC methodologies.

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

• Mentor and provide technical guidance to junior microbiology analysts.

• Liaise with service providers to ensure accurate, on-schedule completion of testing activities, proactively documenting and escalating complaints and deviations as needed.

• Strong knowledge of medical device microbiology, cleanroom control, contamination control, and sterilisation.

• Experience developing microbiology and sterilisation impact assessments and risk assessments.

• Practical experience with environmental monitoring, water testing, bioburden, endotoxin, sterility, particulate monitoring, and EtO sterilisation.

• Strong investigation, problem-solving, technical writing, and data interpretation skills.

• Knowledge of regulated quality systems, including deviations, OOS, CAPAs, NCs, and change controls.

• Ability to make sound, risk-based technical decisions and communicate effectively with cross-functional teams and suppliers.

• Experience leading projects, continuous improvement activities, and technical initiatives.

• Degree in Microbiology, Biotechnology, Life Sciences, or a related discipline.

• Relevant microbiology experience within a regulated medical device, pharmaceutical, or controlled manufacturing environment.

• Demonstrated experience in cleanroom microbiology and contamination control.

• Experience with microbiological/sterilisation impact assessments and EtO sterilisation is highly desirable.

• Experience working within a regulated Quality Management System and with external laboratories and suppliers.

• The opportunity to work in a high-profile, large pharmaceutical company.

• A collaborative and dynamic working environment with strong career progression opportunities.

• Ongoing training and professional development.