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CSV Engineer

Newark Metro Area, NJ

Posted: 06/05/2019 Job Type: Scientific Job Number: JN -062019-25030
  • Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
    * Advanced knowledge of 21 CFR Part 11 compliance and data integrity requirements
    * Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
    * Strong experience writing and executing system validation & equipment qualification documents
  • * BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
    * 10 years of combined experience in FDA-regulated GMP lab environment, minimum 5 years in validation
    Must have experience validating and using common lab equipment and stand-alone computerized lab systems
    Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent
    Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent
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