Immunomedics, Inc.

  • Senior Validation Engineer

    Job Locations US-NJ-Morris Plains
    Posted Date 3 weeks ago(6/4/2018 12:43 PM)
    Job ID
    2018-1202
    # of Openings
    1
    Category
    Engineering
  • Overview

    Ensure satisfactory completion of assigned validation projects encompassing equipment, instruments, cleaning, and process areas for the entire validation lifecycle.  Lead the project team to fulfill the validation requirements.  Develop and execute SOPs and protocols (IQ/OQ/PQ).  Write associated summary reports.  Ensure compliance with the Change Control system for validated state.

    Responsibilities

    • Satisfactorily complete assigned validation projects.
    • Compose validation plans, protocols, and reports
    • Perform IQ/OQ/PQ of appropriate Manufacturing, Microbiology, Cell Culture, and Quality Control equipment; execute process/cleaning and specified system validation
    • Write associated validation summary reports.
    • Investigate and write Non-Conformance Reports (NCRs) when applicable.
    • Write and review appropriate SOPs and other documentation as determined appropriate.
    • Initiate and complete Change Controls.
    • Participate in special teams and projects as appropriate.
    • Conduct routine environmental monitoring (such as water system and differential pressure, etc.) and document review (such as temperature charts, autoclave and depyrogenation oven print-outs, etc.)
    • Strong customer service philosophy required; experience a plus.
    • Must be proficient with MS Office applications.

    Qualifications

    • Bachelor's degree in Engineering or Science required, with at least 7 years of hands-on validation experience in the biotechnology, pharmaceutical, or clinical (GxP) industry; or equivalent combination of education and experience. 
    • Experience managing the full lifecycle of validation projects, e.g., planning, execution, and creation of summary reports.
    • GMP experience is mandatory; familiarity with aseptic processing and clean room environments is strongly desired. Experience with autoclave and depyrogenation oven by using Kaye Validator is a plus. 
    • Experience writing Change Controls, SOPs, protocols, reports and validation documents is required. Investigations experience is a plus.

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