Senior Plant Engineer - GMP Utilities & Systems

PCI Pharma Services; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a Plant Engineer II to provide engineering support across manufacturing facilities, lead critical and plant utility projects, and drive process improvements for water pretreatment, WFI generation, HVAC, Fill Finish, and lyophilization systems.

The role requires a BS in engineering and 9+ years in biotech/pharma facilities with strong project management, GMP knowledge, and experience with CMMS, AutoCAD, SolidWorks, and PLC/SCADA.

Qualifications

• Requires a Bachelor's in Chemical, Mechanical, or related Engineering field.
• Typically 9+ years experience in engineering, facilities clean utilities or plant utilities.
• Strong project management, GMP familiarity, and regulatory compliance knowledge.
• Experience with aseptic filling, lyophilization, Clean Room and related pharma processes is a plus.

Responsibilities

• Support safety and enforce health and safety standards in Plant Engineering.
• Coordinate design, start-up, and qualification of new equipment and facilities.
• Lead FSUE projects from concept to closeout with internal/external teams.
• Prepare URS, ETOPs, risk assessments and safety assessments as required.
• Perform FAT/SAT, commissioning and documentation per Good Engineering practices.

Skills

Project management

Lean principles

GMP compliance

Safety and risk management

Cross-functional collaboration

Education

BS in Chemical/Mechanical Engineering

Tools

AutoCAD

SolidWorks

PLC & SCADA

Job description

PCI Pharma Services is seeking a Plant Engineer II to provide engineering support across manufacturing facilities, lead critical and plant utility projects, and drive process improvements for water pretreatment, WFI generation, HVAC, Fill Finish, and lyophilization systems.

The role requires a BS in engineering and 9+ years in biotech/pharma facilities with strong project management, GMP knowledge, and experience with CMMS, AutoCAD, SolidWorks, and PLC/SCADA.