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Process/Quality/Validation Engineer
Ref No.: 17-04201
Location: Houston, Texas
Experience Level: 4 Years
Start Date / End Date: 01/01/2018 to 12/31/2018
Our need is for an equipment/process Validation Engineer that is self-driven, with a sense of urgency and high integrity, to support newly installed automated and semi-automated manufacturing equipment. Key activities for these equipment and process validations include:
Commissioning & pre-validation studies to establish operational ranges;
Developing IQ, OQ, & PQ validation test protocols;
Executing and reporting validation results and related documentation for the Project History File
Writing/revising manufacturing and machine operating procedures
Supporting transition activities from commissioning to manufacturing startup
Note: This is not an IT position

Must have practical knowledge/understanding of mechanical, electrical, and control systems.
Preferred experience is with automated equipment, including: PLC/HMI controlled systems; robotic and servo pick-and-placement; ultrasonic welding; pneumatic and servo press-to-fit; chemical dispense, laser marking, precision fitments & alignment; CTS testers; and automated conveyance.
Subject matter expert in statistics and statistical design of test protocols, and establishing operational limits for PQ and production for assembly and test equipment.
Prior validation experience with medical device manufacturing/assembly

Engineering BS or equivalent; Mechanical Engineering preferred; Life science, medical technology, statistics helpful.