The Role & What You Will Be Doing
The Microbiology Laboratory Technician II will be responsible for day-to-day microbiological testing (raw materials, waters in-process & finished products) and environmental monitoring (classified areas & compressed gases), including completing the relevant GMP documentation and recording results.
This position also includes report writing, investigation work and review of laboratory raw data.
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 and components for sterility.
Environmental monitoring of classified areas and compressed gases.
Identification of microorganisms to species level.
Growth promotion and sterility testing of microbiological media.
Support the process qualification and stability programs.
Perform test method validations (bioburden, endotoxin & bacteriostasis/fungistasis) and assist in completing the associated reports.
Observing and analysing results from environmental and personnel monitoring plates from classified areas.
Observing and analysing results from microbiological tests (Bioburden/Sterility).
Trending of microbiological test results and results from environmental/personnel monitoring of classified areas.
Inspect media fills.
Monitoring stock levels of media plates and test consumables and ordering when required.
Provide training to other team members as required, ensuring all training delivered is documented appropriately.
Perform Container Closure Integrity testing.
Assist and maintain the Microbiology laboratory calibration schedule.
Complete laboratory investigation reports as assigned.
Complete Grade C and Grade D environmental monitoring trend reports and WFI summary reports as assigned.
Complete review of raw data and laboratory logbooks as assigned.
About Your Skills & Experience
For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Minimum of a Bachelor's degree (or equivalent) in a science-related discipline (preferably microbiology) and 2-4 years' experience within a microbiology department of a pharmaceutical company.
Ability to perform sterility, bioburden and endotoxin testing.
Knowledge of the USP and Ph.Eur.
microbiological requirements.
Ability to prepare and execute comprehensive investigation reports using risk analysis tools.
Experience working within an FDA/HPRA-regulated facility.
Familiarity with the environmental monitoring requirements of a sterile manufacturing facility.
Third-level mathematics ability required.
Excellent attention to detail.
Computer skills including Word and Excel.
Diversity & Inclusion at Viatris
Viatris values diversity, equity and inclusion and encourages applicants whose experience may not align perfectly with every requirement, as they may still be a great fit for this or other roles.
Sustainability at Viatris
Viatris is committed to responsible and sustainable operations, supporting people to live healthier at every stage of life.
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