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Computer System Validation Specialist

Bothell, WA 98021

Posted: 05/18/2023 Job Number: 23928845

Job Description

Hybrid Work Schedule: 2-3 Days Per Week.

Required Skills:
  • 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.

Project Description:
  • The Computer Systems Validation (CSV) Engineer works cross-functionally to lead and execute validation activities for GxP electronic systems and applications.
  • This role is an individual contributor.
  • The CSV Specialist will partner with Business Owners, Technical Owners and Quality to create and manage validation deliverables for electronic systems and applications throughout the validation lifecycle.
  • The CSV Specialist will have primary responsibility to ensure that routine tasks supporting validation of electronic systems and applications are documented in accordance with the relevant procedures and regulations.
  • This includes coordination of system validation periodic reviews and audit activities as well as support of computer system validation efforts for new system implementations and changes to existing systems.
  • 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.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Cheryl: cambrose@alphaconsulting.Com


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Cheryl Ambrose

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