Staff Microbiologist at Dexcom

Simpang Ampat, Penang, Malaysia -

Full Time

Start Date

Immediate

Expiry Date

31 Mar, 26

Salary

0.0

Posted On

31 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Sterilization, Validation, Risk Assessment, Environmental Monitoring, Microbiology, Regulatory Compliance, Documentation, Collaboration, Testing, Audit Readiness, Biocompatibility, Laboratory Testing, Process Qualification, Product Development, Communication

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 Staff Microbiologist will mainly in charge on strategically and collaborate across teams to innovate and implement gentler sterilization methods. Ensuring all cycle changes were validated and documented per ISO 11135 and internal quality systems, maintaining audit readiness and compliance. Maintain environmental monitoring program, conduct investigations, work with quality regulations and guidelines, assess necessary lab adjustments, perform risk assessments, and ensure compliance with sterilization and microbiology testing standard. Where you come in: You maintain regulatory compliance for the sterilization program of sterile implantable devices through process re-qualifications, new product qualifications, and comprehensive risk assessments. You lead and ensure validation and documentation of all cycle changes in accordance with ISO 11135 and internal quality systems, sustaining audit readiness and compliance. You collaborate strategically with global teams to innovate and implement gentler sterilization methods. You drive product adoption and equivalence assessments for new SKUs within existing validated families; author and/or approve validation protocols, reports, and change controls. You review cycle data (e.g., EO dwell time, humidity/temperature, EO concentration) and provide timely release recommendations; monitor trends and continuously improve cycle robustness. You perform EO residual calculations and verification per ISO 10993-7 and internal specifications, coordinate aeration effectiveness evaluations and lot disposition assessments. You prepare storyboards and evidence packages; serve as Subject Matter Expert (SME) during internal and external audits (e.g., BSI, FDA), ensuring continuous audit readiness for Microbiology & Sterilization. You coordinate microbiological testing, product release, and validation protocol testing. You interpret microbiological cultures and related tests, including environmental monitoring, sterility tests, growth promotion, microbial limits, and antimicrobial effectiveness testing. You support environmental particulate and microbial testing for ISO-certified cleanrooms, HVAC systems, compressed air systems, and water systems. You conduct laboratory testing such as bacterial gram staining, growth promotion, microbial identification, endotoxin testing, bioburden recovery, and sterility testing. You manage testing with contract laboratories, including scheduling, sample submission, result review, investigations, and purchase order maintenance. You perform risk assessments for deviations, out-of-specification (OOS) events, CAPAs, NCMRs, and COPs. You develop and execute Performance Qualification and Validation protocols and reports. You design and validate test methods to support microbiology operations. You conduct risk assessments for manufacturing process changes, product development, material biocompatibility, and product modifications. You ensure regulatory compliance for product and material biocompatibility through safety assessments and testing of sterile implantable medical devices for existing and new products. You prepare process and status reports; assign and monitor document numbers; review documents for accuracy and completeness. You perform supplier audits to assess changes impacting sterilization and biocompatibility. You communicate effectively and professionally with internal and external stakeholders. What makes you successful: You have experience in sterilization field (i.e. validation, risk assessment, new product adoption) You have experience in monitoring of environmental systems (i.e. HVAC, Cleanroom, Compressed Air, Compressed Gases, Water). You able to communicate effectively and computer literate. You have industry experience in medical, biopharmaceutical or pharmaceutical or similar environment. 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 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 8-12 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 Staff Microbiologist is responsible for ensuring regulatory compliance for the sterilization program of sterile implantable devices and leading validation and documentation of cycle changes. They will also collaborate with global teams to innovate sterilization methods and perform microbiological testing.