Sr. Microbiologist – Reusables

Tittle : Sr. Microbiologist – Reusables
Duration :12 months
Location: On-site Princeton, Mansfield, or Salt Lake City (Princeton or Mansfield preferred)
Work Hours: Normal business hours
Pay -$61.43/hr. on w2

Additional Requirements:

• Assist with CMP remediation
• Reusable device experience required
• Medical device experience required

• Responsibilities associated with this Sr. Microbiologist – Reusables include working with corporate and various Client sites interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing and reusable devices. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and successfully completing remediation projects.
• The candidate must be a senior-level professional/team player with advanced knowledge and experience who thrives in a team environment but also has the capability to work alone to research and investigate. An understanding of clean room practice/cGMP and laboratory/GLP environments is required. The qualified candidate must understand the concepts of risk management as it relates to microbial monitoring and sterility assurance in a medical device manufacturing environment. This position reports into Global Laboratories, Microbiology, and Sterility Assurance department and works with the client manufacturing sites that manufacture reusable and Codman medical devices.
• Qualified candidates for the contract position must possess relevant experience as a Microbiologist in one or more of the following areas and sufficient knowledge and experience to serve as a subject matter expert within one or more of the areas listed below:
• Controlled environment monitoring
• Water system monitoring
• Bacterial endotoxin test method validation and monitoring
• Bioburden test method validation and monitoring
• Reusable Medical Devices
• Radiation sterilization validation and dose audit management
• Ethylene oxide sterilization validation and requalification
• Reprocessible device cleaning and sterilization validation

• Minimum required education and experience:
• Bachelor’s degree or equivalent with 7+ years of experience, Master’s degree with 4+ years of experience, Doctoral degree with 2+ years of experience.
• Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
• Demonstrates excellent organizational and communication skills.
• Results-oriented with a strong focus on quality principles.
• Excellent technical writing skills with an understanding of good documentation practice.
• Experience conducting microbial test method validations and managing projects independently.
• Experience creating and changing procedures used in operations for microbiological monitoring of the environment and products.
• Working knowledge of applicable microbiology standards including, but not limited to, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 176647, and USP.
• Ability to track milestones and manage projects.
• Working knowledge of applicable regulations and their interpretation within industry.
• Ability to travel 25%.