Join to apply for the Senior Microbiologist role at Dexcom
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Join to apply for the Senior Microbiologist role at Dexcom
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
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 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 with domestic and international standards regarding the day-to-day operation of the Microbiology laboratory, monitoring environmental systems (HVAC/cleanroom, Compressed Air, Water), Product Testing, Sterilization of medical devices, Equipment Qualification, Implementation and Use of LIMS, as well as Training laboratory personnel.
Where You Come In
* You will be involved in setting up the Microbiology Department and its laboratory function, developing protocols to support Microbiology Test Method Validations, Cleanroom Performance Qualification, Equipment, Process Cleaning, and Disinfectant Qualifications, and generating corresponding reports.
* You will work within the Microbiology team, coordinating and supporting all Microbiology activities in line with schedules, company procedures, and standards to ensure regulatory compliance.
* You will review and approve laboratory testing results, support the review of Microbiology procedures, and prepare periodic Microbial testing reports (monthly, quarterly, annual).
* You will assess environmental changes, support Equipment Transfer Plans, perform risk assessments, and coordinate maintenance activities across departments.
* You will lead investigations related to deviations, OOS events, CAPAs, NCMRs, and COPs, and manage environmental monitoring processes.
* You will qualify, calibrate, maintain laboratory equipment, and support the use of LIMS systems.
* You will support additional laboratory operations and responsibilities as directed by management.
What Makes You Successful
* A bachelor’s degree in Microbiology, Biology, or a related Science field.
* 5-8 years of Microbiology experience in medical device, biopharmaceutical, or pharmaceutical industries.
* Knowledge of standards and regulations such as 21 CFR 820, ISO 13485, US and EU Pharmacopeia, AAMI/TIR 52, ISO 14644, 11737, 14971, EN 17141.
* Understanding of environmental systems monitoring, cleanroom microbiology, and sterilization processes is desirable.
* Experience in establishing microbiology labs, test method validation, and equipment qualification is advantageous.
* Effective communication, collaboration skills, self-motivation, project management, and operational management capabilities.
What You’ll Get
* A front-row seat to life-changing CGM technology.
* Comprehensive benefits package.
* Global growth opportunities.
* Access to career development and tuition reimbursement.
* Work in an innovative organization committed to employees, customers, and communities.
Travel Required
* Approximately 5%
Note: Our Careers Site is intended for individuals seeking employment at Dexcom. Only authorized staffing agencies should use this site for submissions. Dexcom does not accept unsolicited resumes or applications from agencies and is not responsible for associated fees.
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