Microbiology Laboratory Technician Level III

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; 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.
We are seeking a Microbiology Laboratory Technician who will be responsible for the day-to-day microbiological testing of raw materials, in-process, finished product and stability product samples and completing the relevant GMP documentation. This position will also include report writing, investigation work and review of raw data/ batch paperwork.

Key expectations:

• Testing of raw materials, in-process & finished products, waters and validation samples for bioburden using membrane filtration or direct method.

• Testing of raw materials, in-process & finished products, waters, validation samples and components for endotoxin using Gel Clot or Kinetic assays.

• Testing of finished products samples, stability samples and components for sterility.

• Environmental Monitoring of classified areas.

• Growth promotion and sterility testing of media supplied to microbiology laboratory.

• Environmental Monitoring of classified areas.

• Observing and analysing results from environmental and personnel monitoring plates from classified areas

• Observing and analysing results from microbiological tests (Bioburden/Sterility)

• Inspect media fills.

• Assist in review of raw data and batch paperwork as assigned

• Writing and completing reports assigned

• Completing IR investigations and reports assigned

• Support the validation programs including process and method validations.

• Assist in the training of new employees when required.

• Assist and maintain the microbiology calibration schedule.

• Assist in the documentation of all test method validations.

Essential experience:

• Ability to perform Sterility, Bioburden and Endotoxin testing.

• Must possess knowledge of the USP and EP Microbiological requirements.

• Ability to prepare and execute comprehensive investigation reports using Risk Analysis Tools.

• Must possess knowledge and have experience of working within an FDA/IMB regulated facility

Qualifications & Experience

• Bachelor's degree in a Science related discipline (Microbiology/Pharmaceutical Sciences)

• 5 years' experience in experience within a microbiology/ quality department within a pharmaceutical company.