Job Description
Are you an experienced Sr Microbiologist-Steriliz with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Sr Microbiologist-Steriliz to work at their company in Billerica, MA.
Primary Responsibilities/Accountabilities:
- 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 the 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 sterilisation 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.
Qualifications:
- 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.
- Cleaning, Disinfection and Resterilization of reprocessable devices
- Controlled Environments
- Has ethylene oxide sterilization experience
Preferred:
- 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.