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Quality/Validation Engineer

Orange County Metro Area, CA

Posted: 08/02/2018 Job Type: Scientific Job Number: JN -082018-22196
Duties:Short term assignment with possibility of extension

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 Alcon 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
Education:Minimum Qualifications:
  • 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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