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System Development/ Validation Engineer
Ref No.: 18-27194
Location: Irwindale, California
•           Coordinate and execute process validation studies, including IQ, OQ, PQ, TMVs, Gage R&R, and Equipment Software Validation as required
•           Understand, plan and conduct Design of Experiments, Process Stability / Control / Capability methods, etc. for process characterizations/equipment development, setting parameters.
•           Develop process solutions by identifying, testing, and controlling factors that influence product performance and manufacturability
•           Interface with quality and manufacturing engineers to review processes, determine validation requirements, and coordinate the validation.
•           Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems associated with the validation program.
•           Write validation protocols and reports as required
•           Coordinate and perform testing relating to the validation
•           Administer validation training for the protocol
•           Write/update work instructions, part specifications, and various forms of reports and correspondence
•           Review the engineering drawings for accuracy
•           Create and process Engineering Change Orders (ECOs)
•           Utilize advanced statistical tools to determine sampling plans and to analyze data associated with validation activities
•           Available for up to 20% travel during critical stages of the projects (both domestic and international)