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Build Test Engineer
Ref No.: 17-00290
Location: NY, New York
Position Type:Contract
Start Date: 07/21/2017
Title – Quality/ Validation Engineer

Candidate can work from home

  • Writes validation protocols and final reports (IQ, OQ and PQ).
  • Documents and reviews standard operating procedures (SOPs).
  • Coordinates the proper approval of plans and protocols
  • Supports regulatory inspections or audits.
  • Validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Traceability Matrix, and Standard Operating ProceduresCoordinates the proper approval of plans and protocols.
  • Knowledge of GxP, GAMP, CFR’s
  • Understanding of the Computer Validation Life Cycle
  • Tracks and coordinates validation change control and/or corrective actions.
  • Serves as information resource for validation technicians, contractors and vendors.
  • 3+ years of applicable work experience in the pharmaceutical or biotechnology industry
  • Understanding of the Validation Lifecycle
  • Understanding of business processes as applicable to computerized systems
  • Understanding of GxP, GAMP, CFR’s as they relate to validation
  • Understanding of how to apply SOPs, work instructions, and regulatory requirements to the validation of computerized systems
  • Understanding of Agile methodology