Immunomedics, Inc.

  • Validation Engineer

    Job Locations US-NJ-Morris Plains
    Posted Date 5 days ago(12/4/2018 12:31 PM)
    Job ID
    2018-1342
    # of Openings
    1
    Category
    Engineering
  • Overview

    Immunomedics, Inc., a biotechnology company located in Morris Plains, NJ, is seeking a Validation Engineer to be responsible for the completion of assigned validation projects encompassing equipment, instruments, computers, cleaning, and process areas for entire validation life cycle.

    Responsibilities

    • Validation activities include:
    • Generating  and executing protocols and writing final reports
    • Project management of overall and individual projects and activities
    • Satisfactory completion of assigned validation projects.
    • Performing IQ/OQ/PQ of facility, including the building management system and appropriate Manufacturing and Quality Control equipment; executing process, cleaning, and specified system validations.
    • Investigating and writing Non-Conformance Reports (NCRs) when applicable.
    • Writing and reviewing appropriate Standard Operating Procedures (SOPs) and other documentation as appropriate.
    • Initiating and completing Change Controls.
    • Generating and/or reviewing user requirement specifications for clean utilities and processing equipment.
    • Reading and interpreting P&IDs, equipment manuals, and electrical/mechanical drawings.
    • Evaluating equipment or process problems and designs testing to determine possible causes or solutions.
    • Providing Technical Support to Manufacturing, QA, QC, etc.
    • Participating in special teams and projects as necessary.

    Qualifications

    • Bachelor's degree in Engineering or Science and a minimum of 2-3 years post-educational validation experience in a cGMP the biotechnology or pharmaceutical manufacturing setting are required.
    •   Candidates without hands-on validation experience outside of their educational institution will not be considered. Engineering background with knowledge of WFI, clean utilities, and general pharmaceutical plant infrastructure.  Experience with FDA, EMA, and other regulatory standards and requirements for clean utility processes strongly desired.
    • Candidate must have a very strong background in GMP utility systems(HVAC-Heating, Ventilation, and Air Conditioning, WFI, clean steam systems, etc.)
    • Background in SCADA or BMS desired.
    • Candidates must have experience managing the full life cycle of validation projects, i.e., 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.
    • Must possess excellent written and verbal communication skills.
    • Salary will be commensurate with experience, plus a comprehensive benefit program.  

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