Sr. Computer Systems Validation Analyst

Foster City, CA, US • Posted 60+ days ago • Updated 1 hour ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • SCADA
  • Programmable Logic Controller
  • URS
  • DirectShow
  • DS
  • IQ
  • OQ
  • PQ
  • GxP
  • Computerized System Validation
  • GAMP
  • Verification And Validation
  • Change Management
  • Documentation
  • Process Control
  • Project Planning
  • Risk Assessment
  • Traceability Matrix
  • Standard Operating Procedure
  • Management
  • Reporting

Summary

Roles & Responsibilities:
  • Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk
  • Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for process control systems.
  • Author documents related to GxP Systems
  • Draft Requirements and computer systems validation documents using GAMP 5
  • Execute test protocols for the software validation.
  • Initiate and execute change management for existing qualified systems.
  • Develop change management record, create or revise documentation if required, and execute implementation tasks.
  • Use understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system
  • Maintaining the project plan/schedule to meet deliverable commitments.
Education & Experience:
  • User and Configuration Specifications
  • System Impact Assessments
  • Risk Assessments
  • Installation Qualification Protocols
  • Operation Qualification Protocols
  • Performance Qualification Protocols
  • Traceability Matrix
  • Summary Reports Standard Operating Procedures
  • Authoring Change Controls
  • Authoring and executing test protocols
  • Managing Issue Reporting, Deviations and related CAPAs
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 8325c0ff9714d2236dc2aa22f1895064
  • Posted 30+ days ago
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