Principal Facilities Engineer

Integra LifeSciences•Braintree, MA

1d•$125,350 - $172,500•Onsite

About The Position

The Principal Facility Engineer serves as the senior technical authority for the Integra LifeSciences Braintree manufacturing facility, providing leadership and oversight for facility infrastructure, utilities, maintenance engineering, capital projects, and continuous improvement initiatives that support medical device manufacturing operations. This role is responsible for ensuring the reliability, compliance, safety, and operational effectiveness of all building systems, manufacturing support utilities, and facility assets. The Principal Facility Engineer leads complex capital and infrastructure projects while providing advanced troubleshooting expertise for electrical, electronic, mechanical, automation, HVAC, and utility systems. The position serves as a key partner to Operations, Quality, Validation, EHS, Supply Chain, and Corporate Engineering teams to ensure regulatory compliance, uninterrupted manufacturing operations, and achievement of site business objectives. Additionally, the role leads facility-related non-conformance investigations, root cause analyses, and CAPA activities, utilizing structured problem-solving methodologies to drive sustainable corrective actions and continuous improvement throughout the site.

Requirements

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.

Nice To Haves

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.

Responsibilities

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, 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.
Serve as the site's primary technical expert for diagnosing and resolving complex facility and manufacturing support system failures.
Troubleshoot electrical systems including: Electrical distribution panels, Transformers, Generators, UPS systems, Static Invertors, Power monitoring systems.
Troubleshoot electronic and automation systems including: PLCs, Human Machine Interfaces (HMIs), Sensors and instrumentation, Building automation controls, Environmental monitoring systems, Variable Frequency Drives (VFDs), Networked control systems.
Troubleshoot mechanical systems including: HVAC equipment, Chillers, Boilers, Air handling units, Pumping systems, Compressed air equipment, Hydraulic and pneumatic systems, 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.
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.
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: Root Cause Analysis (RCA), 5-Why Analysis, Fishbone (Ishikawa) Analysis, Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA), 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.
Ensure compliance with: FDA Quality System Regulations (21 CFR Part 820), ISO 13485 requirements, OSHA regulations, NFPA standards, National Electrical Code (NEC), Environmental regulations, 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.
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, 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.