The instrument process engineering technician provides technical and sustaining engineering support to the instrument product engineering organization. This position will use technical knowledge of operations, processes, and equipment to aid in the completion of projects aimed at reducing costs, improving quality, improving reliability, expanding production capacity, developing new technologies, and maintaining regulatory compliance to cGMP requirements and ISO13485 regulations.
The instrument process engineering technician will be able to develop process validation documents, IQ/OQ/PQ's, and other documents as required for new equipment installs/upgrades, PMs, or troubleshooting. The instrument process engineering technician will also coordinate all aspects of engineering projects assigned. The incumbent in this position will coordinate the schedules for equipment and/or processes for validation and engineering runs, and execute engineering DOEs. The technician will adhere to all plant quality, safety, and documentation systems requirements.
The instrument process engineering technician will support investigations of Deviations/NCMRs, troubleshooting and assisting in solving complex processes and equipments. The instrument process engineering technician interacts with new product introduction teams, engineering, planning, and manufacturing to coordinate introduction of new processes, engineering, and validation runs.
Routine responsibilities include continuous support of the instrument manufacturing process; new product/part introduction; monitoring and support of key manufacturing processes; conduct investigations and troubleshooting of process failures; providing summary results of findings and recommendations to MRB.
Requires a BS degree in engineering/life science, or demonstrated experience in cGMP/ISO13485 environment in validation or process engineering; ability to effectively communicate (verbal and in writing) complex information and data. Position requires work in instrument manufacturing environment, which requires ability to wear laboratory personal protective equipment as required. Also, must be proficient with computers and spreadsheets, word processing, database, and MRP system (JDE preferred); must be able to keyboard for periods of time. Position requires travel 0-10% of the time.