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Validation Engineer

Company: Tek Energy LLC.
Location: Seattle
Posted on: February 20, 2021

Job Description:

Role: Validation Engineer LeadLocation: Seattle, WADuration: Long Term Contract Primary Skill Set

  • 5+ years of direct experience with CSV activities preferably with MES system, strong knowledge of GAMP, risk-based approaches to validation and good understanding of electronic records and signatures
  • 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, Design Specs, Test Scripts (IQ / OQ / PQ), Summary Reports, Trace Matrices, SOPs)
  • Familiar with diverse computerized systems: ERP, LIMS, Validation Lifecycle Software, QMS, Learning Management System, Safety Database
  • Experience in following CSV methodology for implementing and maintaining Infrastructure (IaaS), Platform (PaaS) and SaaS systems.Roles and Responsibilities
    • Author applicable CSV documentation.
    • Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
    • Assist Business Owners and Technical Owners during test execution, document test failures and ensure testing aligns with internal procedures.
    • Ensure the validation of computerized systems used across GxP operations is conducted in compliance with applicable regulatory requirements and internal procedures. Thanks & Regards,Sekhar Paidipala - LinkedIn Senior IT Recruiter, TEKenergy llc 9901 East valley Ranch Parkway, Ste#3045, Irving, TX-75063 Mail : - Direct: Desk: Ext. 109 - Fax: (972)-"Certified Minority Owned Business Enterprise (MBE)" - provided by Dice

Keywords: Tek Energy LLC., Seattle , Validation Engineer, Engineering , Seattle, Washington

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