Facilities & Maintenance Engineer

Terumo Medical Corporation

Facilities and Maintenance Engineer ensuring reliable, validated infrastructure for Terumo’s medical-device manufacturing sites in Caguas. Leading maintenance programs, compliance, troubleshooting, capital projects, and continuous improvement.

Posted 8/12/2026full-timeCaguas • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in facilities and maintenance engineering within regulated manufacturing environments, with a strong focus on GMP compliance, preventive and predictive maintenance methodologies, and effective project management. Proficient in data analysis and troubleshooting to enhance asset performance and ensure operational reliability.

Highest-signal resume keywords

GMP CompliancePreventive And Predictive MaintenanceCMMS SystemsRoot Cause AnalysisProject Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

TroubleshootingData AnalysisMaintenance Program DevelopmentTechnical DocumentationValidation ProcessesCalibration ProcessesMaintenance PlanningRoot Cause Analysis (RCA)Cost-Control ImprovementsAsset Performance

Soft Skills

Effective CommunicationInfluencing Without AuthorityProject CoordinationPrioritizationQuality Mindset

Tools & Technologies

CMMSBuilding Management Systems (BMS)AutoCAD

Certifications & Qualifications

Bachelor’s Degree in EngineeringKnowledge of FDA RegulationsKnowledge of ISO 13485Knowledge of EHS and OSHA Standards

Industry Keywords

GMPRegulated ManufacturingMedical DevicesPharmaceuticalBiotech

About the role

Key responsibilities & impact

Ensure reliability of GMP-critical facility, utility, and equipment systems, including HVAC, electrical, compressed air, water systems, and fire protection
Develop, optimize, and sustain preventive and predictive maintenance programs through CMMS
Define maintenance frequencies, job plans, and spare parts strategies
Maintain FDA, ISO 13485, GMP, and QMS compliance and audit readiness
Support IQ/OQ/PQ, requalification, calibration coordination, and change control activities
Diagnose complex equipment and system failures and lead root cause analysis, deviations, and CAPAs
Analyze CMMS and performance data including downtime, MTBF, and MTTR
Implement asset performance, maintenance effectiveness, and cost-control improvements
Provide technical input and execution support for facility installations, upgrades, and modifications
Support EHS programs, risk assessments, and contractor oversight
Support manufacturing, laboratory, and warehouse operations at TPR1 and TPR2

Requirements

What you’ll need

Bachelor’s Degree in Science of Mechanical Engineering, Electrical Engineering, Electronic Engineering, or any Engineering related field
Minimum 5 years of experience in facilities and/or maintenance engineering within regulated manufacturing, such as medical devices, pharmaceutical, or biotech
Knowledge of GMP regulations, FDA, and ISO 13485
Knowledge of facilities, utilities, and industrial equipment systems
Knowledge of preventive and predictive maintenance methodologies
Knowledge of CMMS systems and maintenance planning
Knowledge of validation and calibration processes
Knowledge of EHS and OSHA standards
Skills in troubleshooting and root cause analysis (RCA)
Skills in maintenance program development and optimization
Skills in technical documentation and GMP compliance writing
Skills in data analysis, including MTBF, MTTR, and downtime trends
Solid project management skills, including planning, scheduling, resource coordination, and execution of facility and maintenance projects within GMP-regulated environments
Ability to manage multiple priorities in a regulated manufacturing environment
Ability to make sound engineering and maintenance decisions
Ability to influence without authority
Ability to communicate effectively in English, written and verbal
Bilingual English/Spanish
Strong compliance and quality mindset
Preferred experience with CMMS optimization and maintenance planning
Preferred experience supporting validated utilities and systems
Preferred knowledge of Building Management Systems (BMS)
Preferred AutoCAD or technical drawing review experience
Preferred reliability engineering or TPM concepts

Benefits

Comp & perks

Annual bonus
Paid vacation
Paid holidays
Health benefits
Dental benefits
Vision benefits
401(k) with matching contributions
Tax advantage savings accounts
Legal plan
Voluntary life and AD&D insurance
Voluntary long-term disability
Short term disability
Critical illness and accident insurance
Parental leave
Personal leave
Tuition reimbursement
Travel assistance
Employee assistance program