• Senior Microbiologist

    Job Location(s) US-NJ-Mahwah
    Posted Date 3 weeks ago(9/29/2018 8:05 PM)
    Job ID
    2018-29612
    Category
    Engineering
    Position Type
    Contract (Full-Time)
    # of Openings
    1
  • Overview

    ***Sterilization Engineer*** 

    Responsibilities

    • Apply cGLP, cGMP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines to the bioburden, cytotoxicity, bacterial endotoxin, and biocompatibility analysis of orthopaedic implants and surgical instruments.
    • Actively support new product development activities.
    • Participate in the development and improvement of the manufacturing processes for existing and new products.
    • May lead in the development, review and approval of sterilization process and equipment validation/qualifications (IQ, OQ & PQ).
    • Be the point of contact for suppliers for new process development, quality issues and process improvements for assigned projects.
    • Support product transfers to other plants/facilities.
    • Review/approve nonconforming material and system documentation.
    • Review/approve product and process change control documentation and specifications.
    • Act as mentor to others. *Willing to review candidates with Microbiologist background*

    Qualifications

    • Bachelor’s Degree in Biology, Microbiology, or a closely related life science. Identify, isolate and study microorganisms and their byproducts as it relates to the manufacturing and sterilization of medical devices.
    • Practice two or more of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat.
    • Review biocompatibility tests and interpret the associated industry guidelines. Work with operations and research groups to develop new products and support continuous quality improvement initiatives.
    • 5+ years of applied device or pharmaceutical microbiological or biological testing, research and development, or sterility assurance experience.
    • Must understand the fundamentals of two of the following sterilization techniques: gamma irradiation, ethylene oxide, hydrogen peroxide gas plasma, moist heat, or dry heat.
    • Demonstrated experience with biocompatibility tests, ability to interpret the associated industry guidelines.
    • Prefer demonstrated competency in advanced testing technologies.
    • Demonstrated knowledge about a variety of microbiological concepts, practices, and procedures.
    • Ability to use ISO, AAMI, USP, ANSI, EPA, EU and related guidelines toward the design, manufacturing, development, and launch of initiatives.
    • Ability to effectively work cross-functionally with Product Development, Operations and Marketing.
    • Demonstrated ability to manage workload.
    • Demonstrated communication skills across different organizational levels.
    • Must be results oriented, a quick learner, team player and able to respond to the urgent needs of the team ensuring all deadlines are met.
    • Demonstrated ability to technically mentor associate engineers and scientists.

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