The Senior Process/Automation Engineer, Manufacturing 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.
Bachelor of Science in appropriate engineering discipline (chemical, mechanical) with at least 5 years’ experience working in a process engineering role preferably in a GMP environment.
Experience working in small teams.
Experience in process simulations.
Proven work experience in process engineering.
Excellent technical skills.
Working knowledge of monoclonal antibody processes, equipment, automation and engineering software packages
Must possess excellent communication (oral and written), organizational, and interpersonal process related standards.
Working knowledge of process engineering software packages