Sr Microbiologist-Steriliz

Billerica, Massachusetts
August 6, 2025
$55 - $60 / hour
Contract
Apply Now

Apply for this job

Upload CV (doc, docx, pdf)

Job Description

TECHNICAL SKILLS:

  • Cleaning, disinfection and reserialization of reprocessable devices
  • Controlled Environments
  • Has ethylene oxide (EO) sterilization experience

Nice To Have (HM’s Preferred Skills):

  • Practical experience with sterilization, microbiology and controlled environments.
  • Standards and guidelines applicable for this role include, but are not limited to, ANSI/AAAMI/ISO 17665-1, ISO 17664-1 and -2, AAMI TIR12, AAMI TIR30, ISO 11135, ISO 11737-
  • ANSI/AAMI ST72, ISO 11737-1, ISO 14644 (series), EN 17141.
  • AAMI Certified Industrial Sterilization Specialist in Ethylene Oxide

HM’s Top Needs:

  • Practical experience with sterilization, microbiology and controlled environments. Standards and guidelines applicable for this role include, but are not limited to, ISO 11135,
  • ANSI/AAMI ST72, ISO 11737-1 and -3, ISO 17664, ISO 17665, ISO 14644 (series), EN 17141.
  • Ability to think critically to develop complex plans and execute actions according to plan
  • Self sufficient and able to drive completion of work with minimal guidance/direction
  • Education Required: Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
  • 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 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 sterilization 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.
  • 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.

Required Knowledge and Experience:

  • 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.

Related Jobs