Immunomedics, Inc.

Validation Engineer

US-NJ-Morris Plains
3 weeks ago(11/30/2017 9:09 AM)
Job ID
2017-1045
# of Openings
1
Category
Scientific 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

Primary 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

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.  

     

    United States work visa sponsorship is not available for this position.  Please note that Immunomedics, Inc. is not an E-Verify employer and cannot assist EAD holders in extending their OPT authorization. At the time of application, please indicate if you have legal authorization to work for Immunomedics, Inc. in this role.

     

    Please apply only if you meet all of the required qualifications listed above and provide salary history and/or expectations at the time of application.  Resumes without specific salary information will not be considered.

     

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