Microbiologist III

Peak Performers has partnered with a global pharmaceutical company to assist in their search for an onsite Microbiologist III in Mansfield, MA or Princeton, NJ. In this contract position, you will be responsible for working with various company sites interpreting microbiological testing data, monitoring, and providing remediation support for the sterility assurance program used in medical device manufacturing.

Major duties

• Generation and execution of microbial method validation protocols and reports including the writing, routing and approval of summary documentation.
• Design experimental plans to address specific microbiological quality issues as needed.
• Manage sample/testing processing with onsite and third-party labs, ensure timely testing and result reporting.
• Ensure compliance of microbiology procedures, validations, and records with all company policies and procedures and appropriate regulations, including, but not limited to, FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO 14698, ISO 11137, ISO 11135, AAMI ST98, ISO 17664, CMDR, Medical Device Directive, and USP.
• Interpret microbiological data in order to identify trends and issues that require investigation and/or remediation.
• Contribute to risk management activities including PFMEA generation and gap assessments.
• Scheduling coordination, material allocation and alignment of personnel in order to successfully complete project assignments.
• Create site procedures for microbiological testing and sampling in alignment with global procedures, validations and in compliance with application regulations.
• Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary, including supervision of contract resources.
• Ensure that all projects are in compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements.
• Support and address comments and suggestions associated with sterilization and microbiological test method validations and monitoring procedures.
• Change control, non-conformance and CAPA support as a microbiology and sterility assurance subject matter expert.
• Support the department manager with coordinating workflow, and providing guidance in the resolution of problems or areas of concern. 
  
  

What are we looking for?

• Bachelor’s degree or equivalent with 7 years of experience, Master’s degree with 4 years of experience, or Doctoral degree with 2 years of experience. Bachelor’s, or preferably Master of Science degree, in Microbiology or similar discipline.
• 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 remediation projects. 
• An understanding of clean room practice/cGMP and laboratory/GLP environments is required.
• 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%.
  
  

Exciting Opportunity Details

• Rate: $58.20.00/hour
• W2 Contract
• Worksite Location: Mansfield, MA or Princeton, NJ
• Onsite
• 12 month contract
  
  

The Peak Performers difference

• Excellent medical health, dental & vision insurance at 60 days
• Our employees may choose to participate in a 403(b) retirement plan
• Qualified applicants with chronic medical conditions and/or disabilities receive priority placement
• We pay weekly through direct deposit
• In business since 1994 and thousands of job placements
  
  

All employment offers are contingent on the successful completion of a pre-employment criminal background check, in compliance with all applicable federal and state laws.

Applicants for employment with Peak Performers must possess work authorization that does not require sponsorship for a visa now or in the future.

Peak Performers is an equal opportunity employer and will consider all applicants without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Peak Performers does not accept unsolicited resumes from headhunters, recruitment agencies or fee-based recruitment services.