Sr Microbiologist-Steriliz

Job Description

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 the company.
• 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.
  
  

Nice to Have

• 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.
  

The Planet Group of Companies is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.