Senior Plant Engineer - GMP Biopharma Systems

PCI TRGR Penn Pharmaceutical Services Ltd; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

PCI Pharma Services is seeking a Plant Engineer III to provide engineering support across manufacturing areas, driving equipment improvements, process optimization, and capital projects. You will lead start-up, validation, and qualification activities for new and existing facilities, utilities, and systems, while ensuring cGMP adherence and safety standards.

The role requires a strong background in chemical/mechanical engineering, 5–7 years in a similar setting, and proficiency with Lean

Qualifications

• Bachelor’s degree in Chemical, Mechanical, or related engineering field preferred.
• 5–7 years’ experience in engineering in a cGMP environment; equivalent education/experience considered.
• Strong understanding of project management, GMP practices, reliability, and lean principles.

Responsibilities

• Support safety initiatives and promote accountability within Plant Engineering.
• Coordinate design, procurement, installation, and startup for new equipment and systems.
• Lead engineering runs to test equipment and troubleshoot problems.
• Prepare documentation of deviations, CAPAs, and NCs; ensure compliance with EH&S and site quality systems.
• Develop system requirements with end users and validate equipment performance.

Skills

Engineering

Project management

cGMP experience

Lean principles

Communication

Education

Bachelors in Chemical/Mechanical Engineering

Tools

IQ/OQ protocols

Job description

PCI Pharma Services is seeking a Plant Engineer III to provide engineering support across manufacturing areas, driving equipment improvements, process optimization, and capital projects. You will lead start-up, validation, and qualification activities for new and existing facilities, utilities, and systems, while ensuring cGMP adherence and safety standards.

The role requires a strong background in chemical/mechanical engineering, 5–7 years in a similar setting, and proficiency with Lean