Microbiologist 2

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 II is an experienced individual contributor responsible for independently performing microbiological testing, leading investigations, and ensuring compliance of microbiology laboratory and environmental monitoring programs. Where you come in: You coordinate environmental monitoring programs for cleanrooms, HVAC, compressed air/gas, and 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 perform and troubleshoot microbiological and environmental monitoring testing activities. You execute activities supporting laboratory upkeep and the environmental monitoring (EM) program. You coordinate testing with contract laboratories, including scheduling, sample submission, results review, investigation support, and Purchase Order (PO) management. You manage laboratory inventory to ensure availability of materials and consumables for testing. You support assessment of cleanroom changes through the Equipment Transfer Plan program. You coordinate with cross-functional teams (QA, Facilities, Engineering, Contract Labs) to support operations and compliance. You support and coordinate risk assessments for deviations, OOS events, CAPAs, NCMRs, and COPs. You prepare Experimental Requests to support special studies and projects. You develop and support Performance Qualification (PQ) and validation protocols and reports. You develop and execute test method validation activities for microbiology operations. You support validation, technology transfer, troubleshooting activities, and contribute to procedure development for quality initiatives. 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 assigned tasks in accordance with established Standard Operating Procedures (SOPs) and cGMP requirements. You support or participate in supplier audits related to microbiology and biocompatibility, as applicable. You support audit readiness and participate in internal and external audits. You drive continuous improvement initiatives in laboratory operations and testing methods. What makes you successful: You have experience in experience in monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water). You have industry experience in medical, biopharmaceutical or pharmaceutical or similar environment is preferred. 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 is preferred. You have experience in maintaining, supporting, and developing test methods for sterilization of medical devices and biocompatibility testing is preferred. You have experience with pro-longed contact and permanent implantable devices is preferred. 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 employe