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.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
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 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 <85>, <161>, 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.
What you’ll get:
- A front row seat to life changing CGM technology.
- A full and comprehensive benefits program.
- Growth opportunities on a global scale.
- Access to career development through in-house learning programs and/or qualified tuition reimbursement.
- An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
- 5%
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
