Sr Microbiologist at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

14 Apr, 26

Salary

0.0

Posted On

14 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Microbiology, Environmental Testing, Quality Regulations, Risk Assessments, Laboratory Testing, Microbial Identification, Sterility Testing, Regulatory Compliance, Validation Protocols, Equipment Maintenance, Communication, Data Review, Supplier Audits, Document Management, Test Method Development, Biocompatibility Testing

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. Meet the team: The Senior Microbiologist will perform environmental testing and reporting, conduct investigations, work with quality regulations and guidelines, assess necessary lab adjustments, perform risk assessments, and ensure compliance in the Microbiology lab. Where you come in: You coordinate microbiological testing, release of product and testing for validation protocols. You read and interpret microbiological cultures and other related tests including but not limited to environmental monitoring, sterility tests, growth promotion, microbial limits tests and antimicrobial effectiveness tests. You support environmental particulate and microbial testing for ISO certified cleanrooms, Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air Gas Systems, and Pharmaceutical Grade Water Systems. You support laboratory testing including, but not limited to, bacterial gram staining, growth promotion, microbial identification, bacterial endotoxin testing, bioburden recovery, and sterility testing. You support all tasks related to laboratory upkeeping and the environmental monitoring program. You coordinate testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations, creating and maintaining Purchase Orders) You assess changes to cleanroom environments by supporting the Equipment Transfer Plan program. You coordinate and support facility, equipment, and HVAC maintenance events between multiple departments. You perform risk assessments for deviations, OOS events, CAPAs, NCMRs, and COPs. You develop, generate, and support Performance Qualification and Validation protocols and reports. You develop test method validations in support of microbiology operations. You perform risk assessments for changes related to manufacturing process changes, product development, material biocompatibility, and product changes. You develop equipment, products, and process cleaning and disinfection validations. You ensure regulatory compliance of product and material biocompatibility by performing safety assessments and testing for sterile implantable medical devices to support existing products and/or process changes and new products. You may perform validation, technology transfer and troubleshooting, and write policy procedure for quality initiatives. You review and approve environmental monitoring data and laboratory equipment and records. You prepare process and status reports, assign and monitor document numbers and reviews documents for accuracy and completeness. You may perform supplier audits to assess changes impacting sterilization and biocompatibility. You work and communicate effectively and professionally with others inside and outside the company. You maintain regulatory compliance of the environmental monitoring program for the Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air and Gas Systems, and Pharmaceutical Grade Water Systems. You lead the team to properly execute and complete daily tasks per schedule under the guidelines of established Procedures. What makes you successful: You have experience in monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water). You 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, CMDR, and EEC93/42, US and EU Pharmacopeia , , AAMI/TIR 30, AAMI/TIR 52, International Organization for Standardization (ISO) 10993, 14644, 11137, 11737, 14971, and other risk guidance standards. You have experience in maintaining, supporting, and developing test methods for sterilization of medical devices and biocompatibility testing. You have experience with pro-longed contact and permanent implantable devices You able to communicate effectively and computer literate. 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 5-8 years of related experience 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 Senior Microbiologist will perform environmental testing, coordinate microbiological testing, and ensure compliance in the Microbiology lab. Responsibilities include conducting investigations, supporting laboratory testing, and maintaining regulatory compliance.