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Validation Engineer, Automation
Ref No.: 18-00134
Location: Foster City, California
Position Type:Contract
Title: Validation Engineer, Automation
Location: Foster City, CA
Type: Contract

Responsibilities:
  • Computer System Validation processes experience
  • Maintain expertise in current and emerging GMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11).
  • Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope, time and schedule.
  • Expereince in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
Qualifications:
  • Bachelor's degree in scientific or engineering discipline along with 5 plus years of experience in the field of computer systems validation.
  • Ideal computer system validation engineer will have and understanding of Siemens Building Management System (Client)
  • Expereince in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
  • Computer System Validation Engineers must have excellent verbal communication and technical writing skills.
  • Experience with all pertinent industry best practices including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing,Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
  • Working knowledge of the development of protocols for the Validation of complex computer systems (e.g., multiple GAMP classes of systems); Protocol development will include ability to develop Installation, Operational and Performance qualification documents.
  • Ability to plan and manage own work