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Computer Validation Specialist - Remote / Telecommute

Location: Bothell
Posted on: May 26, 2023

Job Description:

Job Description:

Pay Range $64hr - $67hr


  • Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews), coordinating with system owners and Quality in accordance with company procedures and regulatory requirements.
  • Author, review and/or approve applicable CSV documentation.
  • Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.
  • Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
  • Support health authority inspections as a subject matter expert (SME) for routine CSV lifecycle activities (as required).
  • Other related duties as assigned.
  • Bachelor's degree in a life sciences or engineering discipline or equivalent industry experience.
  • 2+ years of direct experience with CSV activities, strong knowledge of GAMP / risk-based approaches to validation and good understanding of electronic records and signatures.
  • Strong knowledge of regulations, current industry practices, and experience with application of guidelines and regulations related to control of computerized systems, electronic records and electronic signatures.
  • Familiar with development of CSV documentation (Validation Plans, Requirements / Specifications / Assessments, Test Scripts [IQ / OQ / PQ], Summary Reports, Trace Matrices, SOPs, etc.).
  • Familiar with diverse computerized systems, such as computer-controlled laboratory instruments (stand-alone), MES, ERP, LIMS, Validation Lifecycle Management Software, QMS.
  • Experience in following CSV methodology for system evaluations, changes and implementations.
  • Ability to work independently.
  • Experience implementing controls directly supporting Data Integrity efforts is a plus.

Keywords: CYNET SYSTEMS, Seattle , Computer Validation Specialist - Remote / Telecommute, IT / Software / Systems , Bothell, Washington

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