Validation Engineer - Software Validation
Houston Metro Area, Texas
Our need is for an equipment/process/software 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
- 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.
- Software validation and/or Computerized Systems Validation (CSV) experience
- Prior validation experience with medical device manufacturing/assembly
Engineering BS or equivalent; Mechanical Engineering preferred; Life science, medical technology, statistics helpful