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CSV Automation Engineer
Ref No.: 18-00540
Location: Foster City, California
Position Type:Contract
Title: CSV Automation Engineer
Location: Foster City, CA
Type: Contract

  • Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ etc.) for process control systems. 
  • Familiar with Rockwell Factory Talk View SE v 7.0 or greater and knowledge of PLC's with a strong background in Rockwell Automation software implemented on a virtual network. 
  • Familiar with Rockwell AssetCentre, PI Historian and networking technologies for industrial control systems. 
  • No programing or coding required, but needs to be familiar with logic and general PLC functionality. Recent work with Rockwell Automation products is required. 
  • Must be experienced in computer system validation using GAMP 5 methodology. 
  • Must have a good understanding of 21 CFR part 11 and Annex 11 and how these regulations relate to a process control system.
This person will be responsible for authoring documents related to GxP Systems and must have recent experience in the creation of these deliverables:
  • Experience with validation methodologies and SDLC best practices.
  • Proficient in current Good Manufacturing Practices (cGMPs), Part 11 and Annex 11 requirements.
  • Experienced in developing validation and data migration methodology for global implementation of systems.
  • Experience in managing multiple projects, developing and managing project schedules. PMP certification is a plus.
  • Exceptional interpersonal skills, including teamwork, coordination, facilitation, and negotiation.
  • Strong leadership and project management skills.
  • Excellent analytical, problem-solving and technical skills.
  • Detailed oriented, systematic and rapid learner.
  • Excellent planning and organizational skills.
  • Exceptional written and verbal communication skills