Immunomedics, Inc.

  • Director Maintenance & Engineering

    Job Locations US-NJ-Morris Plains
    Posted Date 3 months ago(3 months ago)
    Job ID
    2018-1227
    # of Openings
    1
    Category
    Facilities
  • Overview

    Responsible for overseeing the engineering change control process, preventive maintenance system, receipt and qualification of new equipment, calibration activities, Blue Mountain scheduling system, maintenance of the critical spare parts inventory and facilities related projects.

    Responsibilities

    • Manages project and qualification engineers, calibration techs and technicians needed to conduct projects involving production equipment and the facilities as well as maintaining critical equipment in calibration.
    • Oversees any third party engineering firms or projects to deliver results on time and on schedule.
    • Serves as business owner of the Blue Mountain PM/Calibration tracking and scheduling system
    • Establishes and manages lifecycle programs for production and laboratory equipment
    • Serves as the facilities representative on the deviation and change control boards.
    • Supervises and coordinates activities for engineers, project managers and calibration techs responsible for all facility and equipment engineering projects. Manages the calibration team to ensure maintenance of all equipment calibrations within required time limits.
    • Understanding of industry engineering standards for GMP manufacturing and support equipment as well as effective preventive and predictive maintenance practices
    • Ability to read and utilize engineering drawings, specification documents and equipment manuals
    • Knowledge of cGMPs as defined in FDA CFRs
    • Must possess excellent communication (oral and written), organizational, and interpersonal skills, with the ability to perform in a team environment.
    • Strong problem-solving skills
    • Self-Starter with the ability to operate with a minimum of direction
    • Solid basic computer skills

    Qualifications

    • Minimum of 10 years experience as a manager in an operational engineering role preferably in a pharmaceutical GMP environment
    • Experience managing small teams
    • B.S. degree in appropriate engineering discipline

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