Facilities & Maintenance Engineer-TPR

Terumo Puerto Rico L.L.C.; Caguas (PR); On-site; USD 95,000 - 125,000; Full time

Job summary

Terumo Puerto Rico L.L.C. is seeking an experienced Facilities & Maintenance Engineer to ensure reliability, compliance, and lifecycle management for site systems and utilities in a GMP-regulated manufacturing environment.

The role combines engineering expertise with maintenance program ownership, acting as a technical lead for troubleshooting, preventive/predictive maintenance, and continuous improvement to support manufacturing, laboratory, and warehouse operations.

Qualifications

• Bachelor’s degree in mechanical or electrical engineering or related field.
• Minimum 5 years’ experience in facilities/maintenance engineering in regulated manufacturing.
• Experience with CMMS optimization and maintenance planning.

Responsibilities

• Operate and improve GMP-critical facility systems (HVAC, electrical, water, fire protection) for high uptime.
• Develop and sustain preventive and predictive maintenance through CMMS.
• Ensure compliance with FDA, ISO 13485, and QMS; support audits.
• Support IQ/OQ/PQ, calibration, and change control for facilities.
• Lead root-cause analysis and RCA for complex failures to boost reliability.
• Analyze CMMS data (MTBF/MTTR) to improve asset performance.
• Assist with capital projects, upgrades, and maintainability by design.
• Support EHS programs and contractor safety during maintenance.

Skills

Troubleshooting

RCA

Maintenance planning

Data analysis

Cross-functional collaboration

Project management

Education

Bachelor's degree in Mechanical Engineering

Bachelor's degree in Electrical Engineering

Bachelor's degree in Electronic Engineering

Tools

CMMS

Building Management System (BMS)

Job description

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.

Main Responsibilities

% of Role

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.

20%

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.

20%

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.

15%

Support Validation, Calibration & Change Control

Participate in IQ/OQ/PQ, requalification, calibration coordination, and change control activities for facilities, utilities, and maintenance-related systems.

15%

Lead Troubleshooting & Reliability Engineering Activities

Diagnose complex equipment and system failures; lead root cause analysis, deviations, and CAPAs to improve long-term reliability.

10%

Drive Continuous Improvement & Asset Lifecycle Management

Analyze CMMS and performance data (downtime, MTBF, MTTR); implement improvements in asset performance, maintenance effectiveness, and cost control.

10%

Support Capital Projects & Engineering Initiatives

Provide technical input and execution support for installations, upgrades, and facility modifications, ensuring maintainability and compliance by design.

5%

Ensure EHS & Contractor Safety Compliance

Support EHS programs, risk assessments, and contractor oversight to ensure safe execution of maintenance and engineering activities.

5%

Organizational Impact:

Direct impact on equipment and facility uptime, supporting production targets and reducing downtime risk.

Improves maintenance effectiveness and asset lifecycle performance through data-driven decisions.

Ensures inspection readiness and compliance, reducing regulatory risk.

Contributes to cost control through optimized maintenance strategies and reliability improvements

Communication & Influence:

Works closely with Maintenance, Manufacturing, Quality, Validation, and EHS teams.

Provides technical direction to maintenance technicians and external contractors.

Influences decisions on maintenance strategies, asset improvements, and reliability initiatives.

Supports regulatory audits and communicates technical justifications to auditors when required.

Solves moderately complex problems involving equipment reliability, system interactions, and regulatory constraints.

Apply reliability engineering principles to improve maintenance systems and asset performance.

Identifies and implements improvements in maintenance processes, technologies, and tools.

Leadership & Autonomy:

Works with general direction; independently prioritizes tasks and assignments.

Provides technical leadership and coaching to maintenance technicians (no direct reports).

Leads small projects or reliability initiatives across functions.

Exercises judgment within GMP and engineering standards.

Position Requirements:

Knowledge:

• 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.

Skills:

• 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.

Abilities:

• 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)

Education:

Bachelor’s degree in science of mechanical engineering, Electrical Engineering, Electronic Engineering or any Engineering related field.

Work Experience:

Minimum 5 years of experience in facilities and/or maintenance engineering within regulated manufacturing (medical devices, pharmaceutical, biotech)

Certifications / Domain Expertise (Preferred):

• Experience with CMMS optimization and maintenance planning
• Experience supporting validated utilities and systems
• Knowledge of Building Management Systems (BMS)