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Quality/Validation Engineer
Ref No.: 18-01356
Location: Irvine, California
Start Date / End Date: 05/29/2018 to 12/31/2018
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

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