Microbiologist

Akkodis is Seeking a Microbiologist for location of Mansfield MA. This is a 12-month contract Position. Ideally looking for a candidate with experience Medical Device Manufacturing Industry.

Pay Range: $45 - $55/hour; The rate may be negotiable based on experience, education, geographic location, and other factors

Job Duties

• 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 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.
• Work in 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 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.

DESIRED MINIMUM QUALIFICATIONS

• Minimum required education and experience. Bachelors degree or equivalent with 7 years of experience, Masters degree with 4 years of experience, Doctoral degree with 2 years of experience. Bachelors, 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.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, please contact Punit Pathak at 610 445 8219 or Punit.pathak@akkodisgroup.com.

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

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