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Computer Systems Validation Engineer

United States, Piscataway, NJ and various unanticipated locations throughout the U.S. · Job Posted December 10, 2025
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Job Description

Understand and analyze requirements, define tasks and execute them. Involve in preparing documentation for all aspects of the computer system validation life cycle. Design, deliver, support and maintain GxP computerized systems and security of the associated data. Create and review validation plans, user requirement specifications, functional/design specifications, system integration and user acceptance test design and traceability matrix. Validate models for risk management and compliance. Coordinate with offshore team in an onsite-offshore model.

Job Responsibility

  • Understand and analyze requirements, define tasks and execute them
  • Involve in preparing documentation for all aspects of the computer system validation life cycle
  • Design, deliver, support and maintain GxP computerized systems and security of the associated data
  • Create and review validation plans, user requirement specifications, functional/design specifications, system integration and user acceptance test design and traceability matrix
  • Validate models for risk management and compliance
  • Coordinate with offshore team in an onsite-offshore model

Requirements

  • CAPA
  • CGXP
  • GAMP
  • HP ALM
  • CSV
  • 21 CFR
  • Audit Trial
  • Agile
  • GAP Analysis
  • Service Now
  • Master’s degree in Science, Technology, or Engineering (any) with 1 year of experience in the job offered or related occupation is required
  • Bachelor’s degree along with 5 years of experience is acceptable

What we offer

Referring employee will be eligible to receive an award of $1,000.00 for the successful referral

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