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Validation Engineer in Fremont, CA at Volt

Date Posted: 11/28/2018

Job Snapshot

  • Employee Type:
  • Location:
    Fremont, CA
  • Duration:
    12 weeks
  • Date Posted:
  • Job ID:
  • Contact Name
    Volt Branch
  • Phone

Job Description

Volt Workforce Solutions is seeking a Validation Engineer in the Fremont CA Area

Candidate will be responsible for generating validation deliverable s, executing validation or qualification documents, leading validation project teams and overall support of the validation project schedule.

Candidate responsibilities

  • Conduct validation or qualification tests of new or existing equipment.
  • Conduct risk assessments for equipment and processes.
  • Develop validation strategies based on regulatory requirements, scientific rationale, industry practice and assessed risk.
  • Generate, execute and report on protocols for the qualification of facilities/utilities/equipment and validation of manufacturing processes.
  • Perform P&ID and I/O verification's.
  • Participate in FAT, SAT, commissioning and startup of new equipment.
  • Provide input to the Facilities Department on preventive maintenance and calibration requirements, including setting appropriate calibration tolerances and frequency of calibration.
  • Assess the re-validation requirements for any equipment modifications or process changes.

Job Requirements

  • Bachelor’s Degree in a field of science. Engineering degree is preferred.
  • 5 years of experience in the cGMP regulated industry. In-vitro diagnostic experience preferred.
  • Good understanding of ISO 13485 and FDA 820 requirements relating to product realization and process validation.
  • Skilled in the setup and calibration of a Kaye Validator for temperature mapping studies.
  • Demonstrated experience in facility/utility/equipment qualification and process validation.

Volt is an equal opportunity employer