Project Engineer, Quality Engineering

Job Overview

We are seeking a highly technical Project Engineer to provide architectural design, engineering support, and technical expertise for GMP and non-GMP utility systems and related equipment within a regulated manufacturing environment. The ideal candidate will possess strong knowledge of HVAC systems, including airflow, process flow, and facility flow, with additional exposure to electrical systems considered a plus. This role requires a hands‑on engineering professional capable of troubleshooting complex facility and utility issues, analyzing system trends, and understanding how systems are designed to operate to ensure reliable and efficient performance.

• Provide engineering support for GMP and non‑GMP facilities, utilities, and related equipment, including troubleshooting, system monitoring, and performance analysis.
• Support and participate in facility and utility system design activities, ensuring adherence to sound engineering and documentation practices.
• Investigate system issues and process deviations, identify root causes, and implement temporary and permanent corrective actions.
• Manage and support quality and compliance activities including change controls, deviations, CAPAs, impact assessments, periodic reviews, and related documentation.
• Analyze operational and performance data trends to identify improvement opportunities and enhance system reliability and efficiency.
• Read and interpret P&IDs, engineering drawings, schematics, and technical documentation to support maintenance, troubleshooting, and system modifications.
• Develop, review, and revise SOPs and technical documentation while ensuring compliance with cGMP requirements, safety procedures, and operational standards.
• Collaborate cross‑functionally with Facilities, Engineering, Operations, Quality, and other departments to drive continuous improvement initiatives and support strategic projects.

• Bachelor's degree in Engineering (Mechanical, Chemical, Electrical, or related discipline).
• 5+ years of experience supporting facilities, utilities, and equipment systems within a GMP-regulated pharmaceutical, biotech, or life sciences environment.
• Strong technical knowledge of HVAC systems, including airflow, pressure relationships, process flow, and facility flow concepts.
• Working knowledge of clean utilities, facility infrastructure, and related mechanical systems; electrical systems knowledge is a plus.
• Demonstrated ability to troubleshoot complex facility and utility system issues, analyze trends, identify root causes, and implement effective corrective actions.
• Experience managing and supporting change controls, deviations, CAPAs, impact assessments, and other quality/compliance documentation.
• Ability to read and interpret P&IDs, engineering drawings, schematics, and technical documentation.
• Strong understanding of cGMP requirements, engineering best practices, safety procedures, and regulatory compliance expectations.
• Experience supporting process improvements, system optimization initiatives, and cross‑functional engineering projects.
• Strong communication, organizational, and problem‑solving skills with the ability to work independently and collaboratively across departments.
• Ability to be on-site, full-time, in West Chester, OH.