Integra LifeSciences

  • Senior Specialist IS Validation

    Vacancy ID
    2017-23450
    Location
    US-NJ-Plainsboro
    Position Type
    Regular Full-Time
    Category
    Information Technology
  • Overview

    Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.

     

    Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery.  In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.


    Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."

    Responsibilities

    Develop validation plans, test plans, design documents, test scripts, validation summary report and traceability matrix for our Oracle ERP and other enterprise systems

    • Qualification of infrastructure and equipment such as Label Printers, Barcode Scanners, and Servers.
    • Maintain knowledge and expertise in compliance with various laws and regulations (GxP, Part 820, 21CFR Part11, Eudralex Annex 11, GAMP5, SOX) and best practices.
    • Develop corporate standards, polices and standard operating procedures (SOPs) for Information Systems.
    • Manage testing in a GxP environment including test script authoring, test script reviews, and resolution of test defects.
    • Manage the change control process for infrastructure and software applications such as Oracle E-business suite and implement changes received from the stakeholders.
    • Identify and develop new policies, procedures, work instructions and other related documents for the IS department.
    • Develop a strong partnership with IS and business users to achieve business and project goals.
    • Travel to Integra facilities or locations for extended periods based on the projects and business needs.
    • Excellent oral and written communication skills.

    Qualifications

    • BA/BS degree in Computer Science or Software Engineering.
    • 6+ years of relevant experience in pharmaceutical/medical device industry.
    • Experience with UDI implementation is a plus.
    • Ability to be involved in multiple full project implementations from project planning to go live especially for ERP systems (Oracle).
    • Thorough understanding of the principles of Computer systems validation, SDLC methodologies and testing best practices.
    • Knowledge of GxP, GAMP5, 21CFR Part11, Eudralex Annex 11 and industry best practices.
    • Experience developing, executing and reviewing validation protocols and deliverables.
    • Software change management experience in the pharmaceutical and/or medical device industries.
    • Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
    • Strong communication and interpersonal skills and the ability to interact with the business, peers and vendors in a professional manner.
    • Ability to work independently with minimal supervision.

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