CSV/ Validation Engineer

Summit, New Jersey
Industry: Admin/Networking/System Engineer
Job Number: JN -072021-66930

Job Description:        

  • The CSV Engineer supports the successful implementation of manufacturing and laboratory equipment and computerized systems at multi-use sites through interaction with internal customers and external service providers. 
  • The incumbent in this role, contributes to the completion of milestones associated with equipment qualification and systems validation. 

Knowledge, Skills & Abilities:

  • Strong working knowledge of MS Windows client and server technologies.
  • Working knowledge of standard networking principles and technologies
  • Excellent understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry
  • Strong working knowledge of ISPE guidance and 21 CFR Part 11 compliance
  • Ability to work with the end user to identify and document User and Functional Requirements
  • Knowledge of pharmaceutical laboratory and manufacturing systems.
  • Experience executing equipment qualification documents
  • Ability to interact effectively with laboratory, QA, and Facilities groups

 Education & Experience:

  • BS degree in Engineering / Computer Science or equivalent
  • Minimum 5 years of experience in FDA-regulated industry, with 5 years experience in CSV.

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