Senior Manufacturing Systems Engineer, Downstream Automation

What you'll do

• Provide automation technical leadership to a group of engineers supporting GMP Drug Substance Plant Operations.
• Develop and maintain the process control system on the Emerson DeltaV distributed control system.
• Transform process requirements from subject matter experts into digital automated solutions.
• Support computerized systems validation processes and maintain Data Integrity Assessments in a GxP environment.
• Lead technical root cause analysis, incident investigations, and troubleshooting for process control issues.
• Manage Change Controls, CAPAs, and Deviations to ensure operational excellence.
• Provide 24x7 onsite and on-call operational support for plant and manufacturing automation systems.
• Prepare and review Standard Operating Procedures (SOP) and cGMP documentation.

What we're looking for

• High School Diploma/GED and 10 years of engineering experience, Associate’s and 8 years, Bachelor’s and 4 years, Master’s and 2 years, or a Doctorate.
• Degree in Electrical Engineering, Computer Science, Chemical Engineering, Biotech Engineering, or a related field (preferred).
• Direct knowledge of automation system design and process control engineering for GMP biopharmaceutical production facility equipment (preferred).
• Extensive background in programming, design, installation, and lifecycle management of manufacturing process controls and field instrumentation (preferred).
• Experience with Emerson DeltaV DCS, Process Control Network design, and integration using OPC, Foundation Fieldbus, Profibus, and DeviceNet (preferred).
• Ability to interpret and apply GAMPs, GMPs, and regulations such as 21 CFR Part 11, ASTM 2500, S88, and S95 (preferred).
• Experience with Capital Project Lifecycle Management and developing process control strategies for New Product Introduction (preferred).
• Doctorate Degree.