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Senior Engineer Microbiology

6.00 to 8.00 Years   Gurugram   13 Feb, 2020
SGTC India
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryTextile / Garments / Fashion
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Seeking a passionate leader of self with the following attributes:

    Sets direction. Prioritize identifies more critical less critical activities and tasks, adjust priorities when appropriate.

    Builds organizational capability. Collaborates effectively with cross functional and divisional partners to achieve goals.

    Developing Talent. Works to develop skills necessary to optimally perform in current and potential future roles.

    .Delivers results. Holds self-accountable to modify behaviors to produce different results when necessary. Monitors own progress in achieving milestones; prioritizes and takes action to keep work on track.

    Communication. Easily communicates thoughts and ideas to stakeholders to bring convergence and proactively reaching out to cross functional and divisional partners to achieve goals.

    • Responsible for handling of microbiology lab simulated reprocessing (cleaning and sterilization -instruments life test) projects.
    • Plan, execute and maintain, qualification and validation of microbiological methods and equipment(s) SOP, protocols reports etc.
    • Cleaning (with protein, hemoglobin and other biochemical markers), disinfectant and sterilization validation of medical devices.
    • Responsible for BI (Biological Indicator), Microbial limit test, growth promotion testing, environment monitoring, water testing and other general microbiological tests and reports required for sterile products.

        • Minimum 6-8 years of work experience
        • Worked with different regulatory bodies (USFDA, EU, PMDA, MHRA etc) production requirements of medical devicespharma etc.
        • Know general microbiology and can demonstrate the test performance understanding.
        • Understanding of different standards like ISO 13485, ISO 17025, Quality Management Systems for Medical Devices 21 CRF 820 and GMP.
        • Strong Instrument Working Knowledge such as, TOC (Total Organic Carbon) analyzer, Spectrophotometer, Centrifuge Machine, Washer Disinfector, Steam Sterilizer, Ultrasonic Bath, Hot Water Bath, Laminar Air Flow, Incubators, Hot Air Oven Freezers (-86 C, -30 C 2-8 C), Air Sampler, Fogger. pH meter Colony Counter other microbiology equipment(s) etc.
        • Experience with medical device pharmaceuticals quality management system and tools, Risk Analysis tools and techniques.
        • Understanding on Medical Device Development Life Cycle process and testing.
        • Understanding of various documentation required for testing.
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