Sr. Microbiologist, CMC

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SUMMARY

Under the direct supervision of the Director, Quality Reliability Microbiology, this individual will have a dotted line reporting structure to the local site quality leader. Responsibilities associated with this Sr. Microbiologist include interpreting microbiological testing data, monitoring, and maintaining the sterility assurance used in medical device manufacturing. The candidate must have experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and 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 working with the CMC Plainsboro, NJ Integra manufacturing site. 

Qualified candidates 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
•    Radiation sterilization validation and dose audit management

•    Ethylene oxide sterilization validation and requalification

•    Reprocessible device cleaning and sterilization validation

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily:

• 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 to identify trends and issues that require investigations.

• Contribute to risk management activities including PFMEA generation.

• Scheduling coordination, material allocation and alignment of personnel 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.

• Mentors non-senior level microbiology staff.

• Serve as Microbiology representative on cross-functional teams for transfer, NPI, and other projects as necessary, including supervision of contract resources.

• Experience with controlled environment monitoring, water system monitoring, compressed air monitoring, bacterial endotoxin test method validation and monitoring, bioburden test method validation and monitoring, ethylene oxide sterilization, radiation sterilization and dose audit management, and reprocessible device cleaning and sterilization validation is strongly preferred.

• 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 an