Job Description
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.
- 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.
Top Skills Needed :
- 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
- Cleaning, disinfection and resterilization of reprocessable devices
- Ethylene oxide sterilization experience
Nice To Have
- 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 11737-3, ANSI/AAMI ST72, ISO 11737-1, ISO 14644 (series), EN 17141.
- AAMI Certified Industrial Sterilization Specialist in Ethylene Oxide
- 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.
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