Validation Engineer - Clinical
Houston Metro Area, TX
The Manufacturing Engineer will lead, execute, document & manage the validation and development activities necessary to support the introduction or revision of production equipment and processes. In addition, the engineer is responsible for assisting or leading process development on the equipment and assisting vendors with equipment integration. As part of this effort, the engineer will assist at times with troubleshooting and corrective actions within production equipment. Basic understanding of PLC programming and functionality, Adept or Motoman robot functionality, statistical process control, Cognex vision systems, pneumatic test systems, and Kinetex Servo programming and use is a plus, but not required.
The Manufacturing Engineer will support the Site process validation, primary packaging validation, cleaning validation and revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies requirements and related SOPs. The Manufacturing Engineer will be responsible to provide guidance in the translation of critical process parameters and the process control strategy into a focused validation plan for process and equipment validations.
Manufacturing Engineers will understand and apply the concepts of Continuous Monitoring to ensure that processes that have been transferred into production are being monitoring & controlled appropriately to maintain the equipment in a validated state. Hands-on support of manufacturing equipment before, during, and after release is expected. Efficiency of process design both from an equipment and overall manufacturing process view is also a key deliverable.
Bachelor's degree in Engineering minimum. Masters or PhD preferred.