Microbiologist 1

Benefits

Additional Information

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: The Microbiologist I is responsible for environmental, compressed gases, and purified water testing and reporting; conducting investigations; ensuring compliance with quality regulations and guidelines; assessing necessary laboratory adjustments; and performing risk assessments to maintain compliance within the Microbiology laboratory. Where you come in: You perform environmental particulate and microbiological testing for ISO-certified cleanrooms, Heating, Ventilation & Air Conditioning (HVAC) systems, compressed air and gas systems, and pharmaceutical-grade water systems. You conduct laboratory testing including, but not limited to, Gram staining, growth promotion, microbial identification, bacterial endotoxin testing, bioburden recovery, and sterility testing. You execute all activities related to laboratory upkeep and the environmental monitoring program. You coordinate testing activities with contract laboratories, including scheduling, sample submission, results review, investigation, and Purchase Order (PO) management. You manage laboratory inventory to support testing requirements. You support assessment of cleanroom changes under the Equipment Transfer Plan program. You coordinate and support facility, equipment, and HVAC maintenance activities across multiple departments. You support and coordinate risk assessments for deviations, Out-of-Specification (OOS) events, CAPAs, NCMRs, and COPs. You prepare Experimental Requests to support special studies and projects. You coordinate and support Performance Qualification (PQ) and validation protocols and reports. You support test method validations for microbiology operations. You support equipment, product, and process cleaning and disinfection validations. You interpret microbiological cultures and related test results, including environmental monitoring, sterility testing, growth promotion, microbial limits testing, and antimicrobial effectiveness testing. You review and approve environmental monitoring data, laboratory equipment records, and related documentation. You prepare process and status reports; assign and track document numbers; and review documents for accuracy and completeness. You ensure regulatory compliance of environmental monitoring programs for HVAC systems, compressed air and gas systems, and pharmaceutical-grade water systems. You execute daily tasks in accordance with established Standard Operating Procedures (SOPs) and cGMP requirements. What makes you successful: You have relevant hands-on microbiological testing experience. Fresh Graduate encourages to apply. You have knowledge of the following standards and regulations: 21 CFR 820, ISO 13485, US and EU Pharmacopeia , , AAMI/TIR 52, International Organization for Standardization (ISO) 10993, 14644, 11737, 14971, and other risk guidance standards. You have experience in maintaining, supporting, and developing test methods for microbiology of medical devices and biocompatibility testing. You have experience with pro-longed contact and permanent implantable devices 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: 0-25% Experience and Education Requirements: Typically requires a bachelor's degree in microbiology, Biology or related field, and a minimum of 0-2 years of related experience To all Staf