Principal Facilities Engineer

Essential Responsibilities

Facility Engineering & Infrastructure Management

• Provide technical leadership for the operation, maintenance, reliability, and continuous improvement of facility infrastructure and manufacturing support systems.
• Manage and support electrical distribution systems, emergency generators and UPS systems, HVAC and environmental control systems, Building Automation Systems (BAS/BMS), compressed air systems, mechanical utility systems, and domestic water and plumbing systems.
• Develop long-range facility master plans, asset replacement strategies, and infrastructure improvement roadmaps.
• Ensure facility systems meet operational requirements while maintaining compliance with regulatory and corporate standards.
• Support business continuity planning and risk mitigation activities for critical facility infrastructure.

Advanced Electrical, Electronic & Mechanical Troubleshooting

• Serve as the site's primary technical expert for diagnosing and resolving complex facility and manufacturing support system failures.
• Troubleshoot electrical systems including distribution panels, transformers, generators, UPS systems, static invertors, and power monitoring systems.
• Troubleshoot electronic and automation systems including PLCs, HMIs, sensors and instrumentation, building automation controls, environmental monitoring systems, VFDs, and networked control systems.
• Troubleshoot mechanical systems including HVAC equipment, chillers, boilers, air handling units, pumping systems, compressed air equipment, hydraulic and pneumatic systems, and lyophilization equipment.
• Lead recovery efforts during critical equipment failures and utility interruptions.
• Analyze recurring failures and implement permanent engineering solutions to improve reliability and uptime.

Capital Project & Program Management

• Lead facility capital and expense projects from concept development through commissioning and project closeout.
• Develop project charters, scopes of work, budgets, schedules, risk assessments, and resource plans.
• Manage multiple concurrent facility engineering projects supporting manufacturing operations and site growth.
• Coordinate activities of contractors, consultants, architects, equipment suppliers, and engineering service providers.
• Oversee facility renovations, infrastructure upgrades, equipment installations, utility expansions, and modernization initiatives.
• Monitor project performance to ensure completion on schedule, within budget, and in compliance with safety and quality requirements.
• Prepare and present project updates, business cases, and financial justifications to site and corporate leadership.
• Support commissioning, qualification, validation, and startup activities for new facility systems and equipment.

Non-Conformance, CAPA & Quality System Leadership

• Lead investigations related to facility, utility, infrastructure, environmental, equipment, and maintenance-related non-conformances, deviations, and quality events.
• Serve as the Facility Engineering Subject Matter Expert during quality investigations and regulatory assessments.
• Conduct comprehensive root cause investigations utilizing structured methodologies including RCA, 5-Why Analysis, Fishbone (Ishikawa) Analysis, FMEA, Fault Tree Analysis (FTA), and Cause Mapping.
• Assess impact to manufacturing operations, product quality, environmental controls, and regulatory compliance.
• Develop and implement corrective and preventive actions (CAPAs) designed to eliminate recurrence and improve system reliability.
• Partner with Quality Assurance, Operations, Validation, Manufacturing Engineering, and EHS teams to establish effective containment and corrective action plans.
• Author investigation reports, engineering assessments, risk analyses, CAPA documentation, and effectiveness checks.
• Verify effectiveness of corrective actions through data analysis, system performance monitoring, and trend evaluations.
• Drive continuous improvement initiatives to reduce repeat failures, utility interruptions, maintenance issues, and facility-related quality events.
• Support internal audits, customer audits, FDA inspections, and ISO certification activities.

Regulatory Compliance & Risk Management

• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485 requirements, OSHA regulations, NFPA standards, National Electrical Code (NEC), environmental regulations, and corporate engineering standards.
• Support change control, validation, commissioning, qualification, and maintenance documentation processes.
• Maintain engineering drawings, equipment records, specifications, PM procedures, and technical documentation.
• Participate in risk assessments and mitigation planning for critical facility systems and utilities.

Reliability & Continuous Improvement

• Implement preventive, predictive, and reliability-centered maintenance strategies.
• Analyze facility performance metrics and equipment reliability trends.
• Develop and monitor KPIs related to CAPA effectiveness, maintenance performance, and project execution.
• Lead energy conservation and sustainability initiatives.
• Apply Lean Manufacturing and continuous improvement principles to optimize facility performance and reduce operating costs.
• Mentor maintenance personnel, facilities technicians, and junior engineers.

Required Qualifications

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, Facilities Engineering, or related engineering discipline.
• Minimum 10 years of progressive experience in facility engineering, manufacturing engineering, maintenance engineering, or infrastructure management.
• Minimum 5 years of experience managing capital projects and cross-functional engineering initiatives.
• Extensive experience troubleshooting electrical, electronic, automation, and mechanical systems in a manufacturing environment.
• Experience with HVAC systems, utilities, building automation systems, power distribution, and industrial controls.
• Demonstrated experience conducting root cause investigations and managing CAPA activities.
• Strong understanding of FDA-regulated or ISO-certified manufacturing environments.
• Excellent leadership, project management, communication, and organizational skills.

Preferred Qualifications

• Certified Reliability Engineer (CRE) certification.
• Experience within medical devices, pharmaceutical, biotechnology, or other highly regulated manufacturing industries.
• Experience with CMMS platforms, BAS/BMS systems, environmental monitoring systems (EEMS), and computerized quality systems.