Facilities & Maintenance Engineer-TPR

Terumo Puerto Rico L.L.C.; Caguas (PR); Hybrid; USD 85,000 - 110,000; Full time

Job summary

Terumo Puerto Rico L.L.C. is seeking an experienced Facilities & Maintenance Engineer to own maintenance programs and lead reliability initiatives across GMP facilities. The role ensures validated, compliant, and inspection-ready systems for manufacturing, laboratories, and warehouses.

Candidates bring 5+ years in regulated facilities/maintenance engineering, strong RCA and CMMS skills, and ability to drive improvements with cross-functional teams in English.

Qualifications

• Bachelor's degree in engineering (mechanical, electrical, electronic or related).
• Minimum 5 years in facilities or maintenance engineering within regulated manufacturing.
• Experience with GMP, FDA, ISO 13485 and QMS compliance.
• Proficient with CMMS and maintenance planning.
• Strong troubleshooting, RCA, and data-driven decision making.
• Excellent written and spoken English; cross-functional collaboration.

Responsibilities

• Ensure reliability of facility, utility and equipment systems.
• Own preventive and predictive maintenance programs.
• Maintain GMP and regulatory compliance and audit readiness.
• Support validation, calibration and change control activities.
• Lead troubleshooting and reliability engineering efforts.
• Drive continuous improvement and asset lifecycle management.
• Support capital projects and engineering initiatives.
• Ensure EHS and contractor safety compliance.

Skills

Troubleshooting RCA

Maintenance program development

Technical documentation

Data analysis

Cross-functional collaboration

Project management

Education

Bachelor's degree in mechanical or electrical or electronic engineering

Tools

CMMS

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.

Working Conditions:

Lifting 50 lbs.<

Travel 20% of Travel

Remote Working Max % 10%

Office Location TPR Adm Building

Direct Reports (#): 0

Indirect Reports (#): 0

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)