Microbiologist 2

Dexcom

Athenry, Ireland

Meet the team:

Are you looking for a new and exciting challenge, one that will leverage and develop your experience to be part of something life changing that helps people take control of their health? Do you enjoy building and managing relationships to better understand the needs of the business, creating and implementing solutions to meet those needs and seeing how you as an individual can positively contribute to those needs? Do you want to be part of a high-performing team dedicated to doing the right thing? If so, then we have an opening for you!

Our Microbiology Department within our Quality Assurance team are looking for a dynamic and skilled Microbiologist II (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, Equipment Qualification, Process Cleaning and Disinfectant Qualifications and generate the corresponding qualification reports
You will work within the Microbiology team and alongside the contract laboratory, supporting, executing and completing 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, interpreting and approving results generated from laboratory testing and be involved in the preparation of periodic Microbial testing reports (e.g. monthly/quarterly/annual EM, Product Bioburden and Product Endotoxin).
You will support the creation and review of Microbiology procedures and documents for accuracy and completeness and be involved in creating and executing
Experimental Requests to support special studies and projects.
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 coordinate and support 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 supporting the Implementation and Use of a laboratory 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.
2-5 years of Microbiology experience within medical device, biopharmaceutical, pharmaceutical or similar industry.
You have knowledge and understanding of applicable standards and regulations e.g., ISO 13485, International Organization for Standardization (ISO) 14644, EN 17141, ISO 11737.
Knowledge and Understanding of the monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water), Cleanroom
Microbiology and Microbiology Equipment Qualifications is required.
Experience in setting up a Microbiology Department/Laboratory function, Test Method Validations and Product Sterilization is desirable.
You must have the ability to communicate and collaborate effectively and cross functionally, be self-motivated and be capable of driving projects to completion.