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Quality/Validation Engineer

Orange County Metro Area, CA

Posted: 05/14/2018 Job Type: Scientific Job Number: JN -052018-21587
The primary scope of this role will be to assist in new equipment, process, and software validation activities particularly related to calibration and quality inspection areas in a manufacturing environment. These validation activities will include development and revision of validation protocols and procedures, develop test plan traceability matrix, IQ/OQ/PQ development, and report preparation.

Responsibilities will include but are not limited to the following:
  • Ensure assigned validation activities are performed timely and in line with current requirements and cGMP
  • Handling any deviations associated with validation activities
  • Author validation protocols and technical reports
  • Execute process and equipment qualitification
  • Perform or oversee risk assessments for validation
  • Assist with the creation or update of Standard Operating Procedures and business processes and tools
  • Must be able to pass all job-specific training or certifications required for core tasks or specialized assignments
  • Proficient in writing and reviewing validation protocols and technical reports
  • Understanding of manufacturing processes and related process equipment
  • Working knowledge of applied statistics, quality systems, and regulatory requirements across multiple health authorities
  • Microsoft Office experience (Excel)
  • Must have critical thinking and problem solving skills
  • Fluent in English
    • Bachelor's degree in engineering or related technical field or relevant engineering-level experience
    • 3+ years experience in manufacturing environment with validation exposure
    • Metrology/Calibration or quality inspection experience is a plus
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