Sr Microbiologist-Sterilization

Responsibilities:

• 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 client.
• Support the development and validation of cleaning, disinfection and sterilization of re-processable 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.

Certifications and Expertise:

• 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.