Sr Microbiologist-Steriliz -

HM's Top Needs:

1. 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.
2. Ability to think critically to develop complex plans and execute actions according to plan
3. 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.