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(CSV) Computer System Validation Engineer

CSV (Computer System Validation) Validation Specialist Greater Boston Area Contract: 12 months Rate: 60-100/hr

My client is seeking to add a Computer System Validation (CSV) Engineer to their team. This CSV Engineer would be responsible for supporting the Computer System Validation (CSV) team with all validation activities related to implementation.

Responsibilities:

  • Complete ownership and review of all Computer System Validation activities including, testing plans, IQ/OQ, test scripts, matrices and more
  • Responsible for final summary of GxP processes
  • Ensuring that all data integrity requirements are met
  • Audit the Quality Systems
  • Review and approval of qualification and Computer System Validation (CSV) compliance
  • Ensure remediation plans are clearly identified and any corrective measures are taken to address them during periodic reviews
  • SOP adherence

Qualifications:

  • Bachelor's degree in a science or computer related field
  • Minimum 4 years of experience within Computer System Validation (CSV)
  • Proficiency of Computer Systems and Quality Systems
  • Proven ability to develop and implement, and manage, CSV programs
  • Advanced within all phases of the Software Development Lifecycle
  • Proven ability to develop or execute validation reports
  • GAMP V, required
  • Knowledge and or exposure to FDA or EU regulations related to Computer System Validation (Annex 11, 21 CFR Part 11 and Part 820)

This is a fast moving opportunity with an industry leader, actively seeking to add this candidate to their team before the end of July. If you, or someone you know, are qualified and interested for this opportunity please forward an updated version of your resume to the attention of Ahmed Hassan and team at Real Staffing, Boston. Thanks!!

Sthree US is acting as an Employment Business in relation to this vacancy.