GMP Facilities & Maintenance Engineer

Terumo Cardiovascular Group; Caguas (PR); On-site; USD 90,000 - 110,000; Full time

Job summary

Terumo Medical Corporation is seeking a Facilities & Maintenance Engineer to oversee the reliability and lifecycle management of facility systems, utilities, and maintenance programs at its manufacturing sites. You will ensure validated, compliant, and inspection-ready infrastructure supporting GMP, FDA, ISO 13485 and QMS requirements.

The role leads troubleshooting, preventive/predictive maintenance, and continuous improvement initiatives that enable high uptime and cost-effective operations

Qualifications

• Bachelor’s degree in Mechanical, Electrical, Electronic Engineering or related field.
• Minimum 5 years of experience in facilities/maintenance engineering within regulated manufacturing.
• Experience with CMMS optimization and maintenance planning.
• Knowledge of Building Management Systems (BMS).

Responsibilities

• Ensure Reliability of Facility, Utility & Equipment Systems by operating and improving GMP-critical systems.
• Own Preventive & Predictive Maintenance Programs through CMMS; define frequencies, plans, and parts strategies.
• Maintain Compliance with GMP & Regulatory Standards including FDA/ISO 13485; support audits.
• Support Validation, Calibration & Change Control activities (IQ/OQ/PQ, requalification).
• Lead Troubleshooting & Reliability Engineering activities; conduct RCA and CAPAs.
• Drive Continuous Improvement & Asset Lifecycle Management using performance data.
• Support Capital Projects & Engineering Initiatives with design-for-maintainability.
• Ensure EHS & Contractor Safety compliance during maintenance activities.

Skills

Troubleshooting RCA

Maintenance planning

GMP compliance writing

Data analysis

Cross-functional collaboration

Project management

Education

Bachelor’s degree in Mechanical/Electrical/Electronic Engineering or related field

Tools

CMMS optimization

AutoCAD

Building Management Systems (BMS)

Reliability TPM concepts

Job description

Terumo Medical Corporation is seeking a Facilities & Maintenance Engineer to oversee the reliability and lifecycle management of facility systems, utilities, and maintenance programs at its manufacturing sites. You will ensure validated, compliant, and inspection-ready infrastructure supporting GMP, FDA, ISO 13485 and QMS requirements.

The role leads troubleshooting, preventive/predictive maintenance, and continuous improvement initiatives that enable high uptime and cost-effective operations