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Sr Microbiologist-Steriliz
Sr Microbiologist-SterilizTALENT Software Services • Billerica, MA, United States
Sr Microbiologist-Steriliz

Sr Microbiologist-Steriliz

TALENT Software Services • Billerica, MA, United States
2 days ago
Job type
  • Full-time
Job description

Are you an experienced Sr Microbiologist-Steriliz with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr Microbiologist-Steriliz to work at their company in Billerica, MA.

Primary Responsibilities / Accountabilities :

  • Responsibilities may include the following and other duties may be assigned.
  • Work relatively independently with guidance and direction from senior members of the staff and the manager.
  • Assure all Quality requirements are in compliance with regulations and product specifications
  • Provide new product development sterilization / microbiology validation support
  • Perform, coordinate, execute, and summarize all areas of sterilization validation (EtO)
  • Work with little guidance to design and validate sterilization cycles for new products including new sterilizer IQ / OQ / PQ reports, calibration, and production support.
  • Work with little guidance to develop, implement and maintain sterilization processes, certifications and procedures for the sterilization operations within Healthcare.
  • Support the development and validation of cleaning, disinfection and sterilisation of reprocessable devices
  • Support internal and external audits
  • Prepare written responses to regulatory questions
  • Review engineering change orders.
  • Resolve non conformances and implement corrective action
  • Work with Facility Maintenance and other departments for any Sterilizer, CEA, or Lab improvement / corrective activities.
  • Participate in special projects as assigned.
  • Reviews Supplier Change Control (SCC) notifications for impact to sterilization / microbial testing.
  • Assuring that the Microbiology / Sterilization function is maintained per industry standards.

Qualifications :

  • Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
  • Cleaning, Disinfection and Resterilization of reprocessable devices
  • Controlled Environments
  • Has ethylene oxide sterilization experience

    • Preferred :

  • Certified Industrial Sterilization Specialist (CISS)
  • Experience in Ethylene Oxide Sterilization validation
  • Thorough knowledge of fundamental microbiology principles, methods, and procedures, including knowledge of bacteria morphology and staining, aseptic technique specifically as they relate to sterilization methods.
  • Environmental Monitoring (EM) subject matter expertise.
  • Expertise in clean room requirements and gowning requirements
  • Ability to multi-task, skilled in planning, organizing, coordinating projects, and working independently.
  • Ability to write protocols, reports, procedures, and work instructions
  • Ability to read and interpret documents related to medical device sterilization and cleanrooms Including : International standards, regulations, technical procedures, journals, regulatory publications. Familiarity with FDA regulations.
  • Working knowledge of MS Word, Excel, PowerPoint, MS Outlook, Project
  • Expertise in cGMP's and quality systems as related to terminally sterilized medical devices.
  • Knowledge in compendial (AAMI, USP, ISO) methodologies and techniques, including : ISO 13485, 11135, 14644 (series), 14698 (series), 17665, 17664, 11737-1 / -2 / -3, and ANSI / AAMI ST72.
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    Sr • Billerica, MA, United States