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Validation/Project Engineer

Houston Metro Area, TX

Post Date: 10/12/2017 Job ID: JN -102017-20223
Description:
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

Skills:
  • 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
Education:
Engineering BS or equivalent; Mechanical Engineering preferred; Life science, medical technology, statistics helpful

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