Plant Engineer I-III: GMP Utilities & Equipment

PCI Pharma Services; Madison (WI); On-site; USD 90,000 - 130,000; Full time

Job summary

PCI Pharma Services in Madison, WI is seeking a Plant Engineer II to provide engineering support across manufacturing facilities, driving equipment improvements, capital projects and qualification activities.

You will collaborate with cross-functional teams to ensure safety, quality, and regulatory compliance while delivering reliable facility systems such as water pretreatment, steam, HVAC, and fill finish equipment.

Qualifications

• BS in Chemical, Mechanical, or other Engineering degree from an accredited university.
• Minimum 9+ years' experience in engineering, facilities clean utilities and/or plant utilities.
• Strong understanding of project management, GMP/GxP, reliability and Lean principles.
• GMP and non-GMP change control, maintaining regulatory compliance.
• Experience with aseptic liquid filling of vials, CIP/SIP and Clean Room, lyophilization, aseptic filling of vials, and aseptic processes, including refrigerated and frozen capabilities a Plus.
• Experience with CMMS, AutoCAD, SolidWorks, PLC & SCADA control system.
• Experience working in a GMP and FDA regulatory environment for drugs and/or medical devices a plus.
• Demonstrated proficiency in basic manufacturing, engineering, and/or scientific theories, principles, and techniques used in biopharma/medical device processes.
• Strong organization, interpersonal, oral and good written communication skills.

Responsibilities

• Support safety through personal engagement and promote accountability within the Plant Engineering Department.
• Establish and streamline practices around equipment and/or facility specification, design, start-up, and commissioning; coordinating fabrication, procurement, installation, engineering start-up, and validation activities.
• Provide engineer support for Facilities, Systems, Utilities and Equipment (FSUE) execution of projects from concept to closeout.
• Design and execution of engineering runs to test equipment or troubleshoot problems.
• Partner with contractors on troubleshooting assistance for issues found in the manufacturing environment.
• Identify and resolve problems; develop alternative solutions and work in group problem solving.
• Work with end users to develop system requirements and perform Factory/Site Acceptance Testing.
• Prepare URS, ETOPs, Risk Assessments and Safety Assessments for FSUE.
• Execute good Engineering practices for new equipment/Systems/ utilities.
• Coordinate with MTS, Automation, Manufacturing, QA, Facility Operations and Maintenance/Metrology, EHS&S, and Quality Control.

Skills

GMP compliance

Project management

Lean principles

Problem solving

Regulatory affairs

Education

BS in Chemical, Mechanical, or other Engineering degree from an accredited university

Tools

AutoCAD

SolidWorks

PLC & SCADA control system

Job description

PCI Pharma Services in Madison, WI is seeking a Plant Engineer II to provide engineering support across manufacturing facilities, driving equipment improvements, capital projects and qualification activities.

You will collaborate with cross-functional teams to ensure safety, quality, and regulatory compliance while delivering reliable facility systems such as water pretreatment, steam, HVAC, and fill finish equipment.