Sr Microbiologist-Steriliz

Sr Microbiologist-Steriliz
Job Summary: Talent Software Services is in search of a Sr Microbiologist-Steriliz for a contract position in Billerica, MA. The opportunity will be nine months with a strong chance for a long-term extension.
Primary Responsibilities/Accountabilities:

• Work relatively independently with guidance and direction from senior 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).
• Design and validate sterilization cycles for new products including new sterilizer IQ/OQ/PQ reports, calibration, and production support.
• Develop, implement, and maintain sterilization processes, certifications, and procedures for sterilization operations.
• 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 actions.
• Collaborate with Facility Maintenance and other departments for any sterilizer, CEA, or lab improvement/corrective activities.
• Participate in special projects as assigned.
• Review Supplier Change Control (SCC) notifications for impact on sterilization/microbial testing.
• Ensure that the Microbiology/Sterilization function is maintained per industry standards.

Qualifications:

• Practical experience with sterilization, microbiology, and controlled environments. Familiarity with standards and guidelines such as ISO 11135, ANSI/AAMI ST72, ISO 11737-1 and -3, ISO 17664, ISO 17665, ISO 14644 (series), and EN 17141.
• Ability to think critically to develop complex plans and execute actions according to plan.
• Self-sufficient and able to drive the completion of work with minimal guidance/direction.
• Requires a University Degree and a minimum of 4 years of relevant experience, or an advanced degree with a minimum of 2 years of relevant 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.

Preferred:

• Certified Industrial Sterilization Specialist (CISS).
• Experience in Ethylene Oxide Sterilization validation.
• Thorough knowledge of fundamental microbiology principles, methods, and procedures, including bacteria morphology and staining, aseptic technique 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, and 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.

If this job is a match for your background, we would be honored to receive your application!
Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities including contract, contract to hire and permanent placement. Let's talk!