The Process Engineer, Utilities/Facilities will be the technical resource providing support to portions of the manufacturing process with the goal of ensuring reliable performance and identifying opportunities for continuous improvement.
• Develops a fundamental understanding of the process and equipment. Utilizes technical and engineering tools to troubleshoot and understand the process.
• Utilizes reports/ data (e.g. UNICORN) to analyze and troubleshoot process issues. Trouble shoots and resolves equipment issues.
• Serves as a technical resource for the process and equipment and SME for change requests, deviations, and periodic quality reviews to ensure equipment remains in a validated/ qualified state.
• Investigates deviations and applies root cause analysis tools to determine root cause(s)and establishes resolution/ implementation of CAPA’s to minimize repetitive deviations.
• Improves process throughput. Utilizes modeling tools to identify bottlenecks and proposes operational or equipment modifications to improve throughput.
• Routinely assesses process using measurements and data interpretation. Utilizes statistical tools to analyze process data to ensure process is in control and capable.
• Provides process documentation and operating instructions. Assists with SOP’s and batch record improvements; composes and obtains approval for new equipment SOP’s.
• Performs risk assessments/ recommendations. Assists with equipment failure risk mitigation, FMEA analysis, process safety assessments, and critical spare part assessments.
• Implements process improvements. Specifies and purchases new equipment for process improvements. Utilizes quality systems (User requirements, IQ/OQ, functional testing, etc.) for validation of new equipment.