Microbiologist 2 at Dexcom

Athenry, Athenry-Oranmore Municipal District, Ireland -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

0.0

Posted On

09 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Quality Assurance, Environmental Monitoring, Sterilization, Equipment Qualification, LIMS, Test Method Validation, Cleanroom Performance Qualification, Risk Assessment, Regulatory Compliance, Laboratory Deviations, CAPAs, NCMRs, Communication, Collaboration, Self-Motivation

Industry

Medical Equipment Manufacturing

Description

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. 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 2 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 training 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 across 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: 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 should be able to communicate and collaborate effectively across functions, be self-motivated, and capable of driving projects to completion. What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. 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% Experience and Education Requirements: Typically requires a Bachelor's degree in Microbiology, Biology or related science discipline and a minimum of 2-5 years related experience or Master's degree and 0-2 years' equivalent experience. 2-5 years of Microbiology experience within medical device, biopharmaceutical, pharmaceutical or similar industry. 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.

Responsibilities

The Microbiologist 2 will ensure compliance with domestic and international standards in the Microbiology laboratory, including monitoring environmental systems and product testing. They will also develop protocols, review laboratory results, and support the qualification and maintenance of laboratory equipment.