Dexcom Jobs – Sr Microbiologist

Website Dexcom

Job Description:

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.

Job Responsibilities:

  • Assesses changes to cleanroom environments by supporting the Equipment Transfer Plan program.
  • Supports laboratory testing including, but not limited to, bacterial gram staining, growth promotion, microbial identification, bacterial endotoxin testing, bioburden recovery, and sterility testing.
  • Coordinates and supports facility, equipment, and HVAC maintenance events between multiple departments.
  • Maintains regulatory compliance of the sterilization program for sterile implantable devices by performing process re-qualifications, new product qualifications, and risk assessments.
  • Coordinates testing with contract laboratories (scheduling, submitting samples, reviewing results, conducting investigations, creating, and maintaining Purchase Orders)
  • Supports environmental particulate and microbial testing for ISO certified cleanrooms, Heating Ventilation & Air Conditioning (HVAC) systems, Compressed Air Gas Systems, and Pharmaceutical Grade Water Systems.
  • Ensures regulatory compliance of product and material biocompatibility by performing safety assessments and testing for sterile implantable medical devices to support existing product and/or process changes and new products.
  • Performs risk assessments for deviations, OOS events, CAPAs, NCMRs, and COPs.
  • Performs risk assessments for changes related to manufacturing process changes, product development, material biocompatibility, and product changes.
  • Develops equipment, product, and process cleaning and disinfection validations.
  • Creates Experimental Requests to support special studies and projects.
  • Develops test method validations in support of microbiology operations.
  • Develops, generates, and supports Performance Qualification and Validation protocols and reports.
  • Supports all tasks related to laboratory upkeeping and the environmental monitoring program.

Job Requirements:

  • Experience with pro-longed contact and permanent implantable devices
  • Microbiology, Biology, or equivalent Bachelor’s degree (B.A./B.S)
  • Experience in maintaining, supporting, and developing test methods for sterilization of medical devices and biocompatibility testing.
  • 3+ years industry experience
  • Knowledge of the following standards and regulations: 21 CFR 820, ISO 13485, CMDR, and EEC93/42, US and EU Pharmacopeia <85>, <161>,
  • AAMI/TIR 30, AAMI/TIR 52, International Organization for Standardization (ISO) 10993, 14644, 11137, 11737, 14971, and other risk guidance standards
  • Experience in monitoring of environmental systems (HVAC, Cleanroom, Compressed Air, Compressed Gases, Water)

Job Details:

Company: Dexcom

Vacancy Type: Full Time

Job Location: Simpang Ampat, Penang, Malaysia

Application Deadline: N/A

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