Plant Engineer III

Plant Engineer III provides engineering support across manufacturing facilities for process improvements, capital projects, and equipment maintenance in a biopharmaceutical contract manufacturing environment. The role involves designing and implementing utility systems, leading critical projects, and ensuring compliance with GMP and FDA regulations.

Responsibilities

• Lead critical and plant utility projects from conception through completion independently
• Design, procure, install, and commission equipment and utility systems including water, steam, and clean air
• Conduct engineering runs to troubleshoot equipment problems and execute factory/site acceptance testing
• Prepare engineering documentation including URS, ETOPs, and risk assessments per GMP standards
• Collaborate with cross-functional teams including manufacturing, quality, maintenance, and EHS to optimize asset lifecycles

Requirements

• BS in Chemical, Mechanical, or related Engineering from accredited university
• 5+ years engineering experience in facilities, clean utilities, or plant utilities
• Strong technical project management, Good Engineering Practices, and Lean Principles knowledge
• Experience with GMP/non-GMP change control and regulatory compliance
• Proficiency with CMMS, AutoCAD, SolidWorks, PLC, and SCADA systems
• Knowledge of GMP and FDA regulatory requirements for pharmaceuticals or medical devices
• Excellent technical writing and communication skills