Facilities & Maintenance Engineer - TPR

Terumo•Caguas, PR

10d•Onsite

About The Position

The Facilities & Maintenance Engineer is responsible for the reliability, compliance, and lifecycle management of facility systems, utilities, and maintenance programs in the manufacturing Sites (TPR1 &TPR2). This role ensures that facility infrastructure and equipment are maintained in a validated, compliant, and inspection-ready state, meeting GMP, FDA, ISO 13485, and internal Quality Management System (QMS) requirements. The position combines engineering expertise and maintenance program ownership, serving as a technical lead for troubleshooting, preventive and predictive maintenance strategies, and continuous improvement initiatives that support manufacturing, laboratory, and warehouse operations.

Requirements

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 (medical devices, pharmaceutical, biotech)
GMP regulations (FDA, ISO 13485)
Facilities, utilities, and industrial equipment systems.
Preventive and predictive maintenance methodologies.
CMMS systems and maintenance planning.
Validation and calibration processes.
EHS and OSHA standards.
Troubleshooting and root cause analysis (RCA)
Maintenance program development and optimization
Technical documentation and GMP compliance writing
Data analysis (MTBF, MTTR, downtime trends)
Cross-functional collaboration
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)
Strong compliance and quality mindset

Nice To Haves

Experience with CMMS optimization and maintenance planning
Experience supporting validated utilities and systems
Knowledge of Building Management Systems (BMS)
AutoCAD or technical drawing review
Reliability engineering or TPM concepts
Bilingual (English/Spanish).

Responsibilities

Ensure Reliability of Facility, Utility & Equipment Systems: Operate, monitor, and improve performance of GMP-critical systems (HVAC, electrical, compressed air, water systems, fire protection) and facility-related equipment to ensure high uptime and operational continuity.
Own Preventive & Predictive Maintenance Programs: Develop, optimize, and sustain preventive and predictive maintenance strategies through CMMS; define frequencies, job plans, and spare parts strategies to improve reliability and reduce downtime.
Maintain Compliance with GMP & Regulatory Standards: Ensure facilities and maintenance activities comply with FDA, ISO 13485, and QMS requirements; maintain audit readiness and support inspections.
Support Validation, Calibration & Change Control: Participate in IQ/OQ/PQ, requalification, calibration coordination, and change control activities for facilities, utilities, and maintenance-related systems.
Lead Troubleshooting & Reliability Engineering Activities: Diagnose complex equipment and system failures; lead root cause analysis, deviations, and CAPAs to improve long-term reliability.
Drive Continuous Improvement & Asset Lifecycle Management: Analyze CMMS and performance data (downtime, MTBF, MTTR); implement improvements in asset performance, maintenance effectiveness, and cost control.
Support Capital Projects & Engineering Initiatives: Provide technical input and execution support for installations, upgrades, and facility modifications, ensuring maintainability and compliance by design.
Ensure EHS & Contractor Safety Compliance: Support EHS programs, risk assessments, and contractor oversight to ensure safe execution of maintenance and engineering activities.