Senior Microbiologist

Senior Microbiologist

Dexcom

Athenry, Ireland

Our Microbiology Department within our Quality Assurance team are looking for a dynamic and skilled Senior Microbiologist (Onsite role) to support the start-up of our first European manufacturing facility in Athenry. In this role, you will be responsible for ensuring compliance to domestic and international standards with regards to the day to day operation of the Microbiology laboratory, the monitoring of environmental systems (i.e. HVAC/cleanroom, Compressed Air, Water), Product Testing, Sterilization of medical devices, Equipment Qualification, Implementation and Use of LIMS as well as the Training of laboratory personnel.

Where you come in:

• You will be involved in setting up the Microbiology Department and its laboratory function, developing and creating protocols to support Microbiology Test Method Validations, Cleanroom Performance Qualification and Equipment, Process Cleaning and Disinfectant Qualifications and generate the corresponding qualification reports
• You will work within the Microbiology team, coordinating and supporting the execution and completion of all Microbiology activities as per defined schedules and in line with established company procedures and current domestic and international standards ensuring regulatory compliance.
• You will be involved in reviewing and approving results generated from laboratory testing, support the review of Microbiology procedures and documents for accuracy and completeness and be involved in the preparation of periodic Microbial testing reports (e.g. monthly/quarterly/annual EM, Product Bioburden and Product Endotoxin).
• You will assess changes to cleanroom environments by supporting the Equipment Transfer Plan program, perform risk assessments for changes related to the manufacturing process, product development and product changes and help coordinate and support facility, equipment and HVAC maintenance events between multiple departments.
• You will lead tasks associated with laboratory deviations, OOS events, CAPAs, NCMRs, and COPs and establish and maintain environmental monitoring excursion communication, reporting, investigation, disposition and corrective action process. 
• You will be responsible for the qualification, calibration and routine maintenance of laboratory equipment and their records as well as the Implementation and Use of laboratories LIMS system.
• You will support any additional tasks related to the general operation of the laboratory and further responsibilities as and when requested by management.

What makes you successful:

• A bachelor’s degree in Microbiology, Biology or equivalent Science discipline.
• 5-8 years of Microbiology experience within medical device, biopharmaceutical, pharmaceutical or similar industry.
• You must have knowledge and understanding of standards and regulations e.g., 21 CFR 820, ISO 13485, US and EU Pharmacopeia, AAMI/TIR 52, International Organization for Standardization (ISO) 14644, 11737, 14971, EN 17141.
• Knowledge and Understanding of the monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water), Cleanroom Microbiology and Product Sterilization is desirable.
• Experience in setting up a Microbiology Department/Laboratory function, Test Method Validations and Equipment Qualifications would be an advantage.
• You must have the ability to communicate and collaborate effectively and cross functionally, be self-motivated, drive projects to completion and be capable of managing the day to day operation of a Microbiology laboratory.

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