Integra LifeSciences

  • Senior Microbiologist

    Vacancy ID
    2018-27143
    Location
    CH-NE-Le Locle
    Position Type
    Regular Full-Time
    Category
    Quality Assurance
  • Overview

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    Integra LifeSciences, founded in 1989 in New Jersey, is a leader in the medical technology market with more than 4'300 associates worldwide. This company supports many health professionals in their work by helping them to improve the quality of patient’s life. Integra offers innovative solutions in several fields of surgery: orthopedics, neurosurgery, general and reconstruction surgery.

     

    Integra LifeSciences Switzerland in Le Locle, specialized in neurosurgery, manufactures a wide selection of medical implants. Nearly 200 associates work there.

    Responsibilities

    Responisbilities:

    • Validate & Manage routine environmental monitoring (clean room, water/air/gas systems, analyze and report results)
    • Manage site bioburden and dose audit programs
    • Carry out microbiology/HPLC laboratory investigation
    • Review and approve laboratory documents & sterilization certificates
    • Ensure the development and implementation of harmonized practices/procedures
    • Investigation of non-conformity and CAPA related to sterilization, contamination & OOS laboratory
    • Develop, validate and/or requalify cleaning, gamma/ethylene oxide and/or steam sterilization processes for existing and new products
    • Support equipment qualification affecting cleanliness/sterilization
    • Review and assess supplier changes from clean/sterilization aspect
    • Lead or coordinate sterility assurance projects
    • Interact with manufacturing, quality teams, contract sterilizers & laboratories
    • Carry out regular internal auditing of clean room facilities and other defined areas
    • Provide internal & external audit support (front room, back room and SME)

    Qualifications

    Qualifications:

    • Bachelor of Science Degree
    • Minimum 3-5 years experiences as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry
    • Proven knowledge of FDA and MDD GMP requirements regarding medical Devices
    • French speaker and Fluent in English
    • Good interpersonal, organizational, oral and written communication skills.
    • Comfortable to work with cross functional teams
    • Teamwork and communication skills to work effectively on cross-functional project teams,
    • interacting with a diversity of disciplines such as R & D, Packaging Engineering, Quality Engineering, Regulatory Affairs, Marketing, etc.
    • Independent, proactive and self-motivated.

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