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.
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.
