Serve as SME for critical systems including purified water, HVAC, Building Management System (BMS), chilled water, and compressed air
Ensure systems operate reliably and in compliance with GMP and quality requirements
Lead troubleshooting of complex system failures impacting production
Drive RCA, CAPAs, and long-term reliability improvements
Serve as the technical lead for capital projects, ensuring sound engineering principles are applied throughout design, specification, and execution
Manage capital projects greater than $1MM from concept through closure, including planning, budgeting, scheduling, and execution
Develop and review engineering documentation including URS, DFMEA, P&IDs, equipment layouts, and scopes of work
Lead all phases of project delivery from planning through closure including FAT, SAT, commissioning, qualification, and verification
Provide hands-on engineering support to plant operations to resolve equipment and system issues
Identify and implement continuous improvement opportunities to enhance reliability, efficiency, and quality

Bachelor’s degree in Engineering (Mechanical, Chemical, Electrical, Biomedical, or related)
Minimum of 6+ years of engineering experience in a cGMP or regulated manufacturing environment
Proven ability to lead capital projects and cross-functional teams
In-depth experience working with facility and utility systems such as purified water, HVAC, and Building Management Systems (BMS)
Strong ownership mindset with the ability to drive projects and technical decisions independently
Demonstrated ability to troubleshoot complex systems and implement effective engineering solutions
Strong communication skills
Proficiency in standard Microsoft Office tools (Excel, PowerPoint, Word)
Working knowledge of AutoCAD or similar tools

Plant Systems Engineer

Key skills