Project Engineer

Job-ID32386890Reference26-00883Job 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.Roles & Responsibilities: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. Requirements: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.