Senior GMP Facilities & Maintenance Engineer

Jobtailor

Caguas (PR)

On-site

USD 90,000 - 130,000

Full time

13 days ago

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Job summary

Jobtailor, a leading life sciences employer in Puerto Rico, seeks a Facilities & Maintenance Engineer to ensure reliable GMP-critical systems across HVAC, electrical, water, and fire protection. You will design and implement maintenance programs, optimize CMMS workflows, and support validation activities in a regulated manufacturing environment.

The role requires a bachelor’s in engineering and at least 5 years of experience in regulated manufacturing, with strong problem-solving, documentation,

Qualifications

  • Bachelor's degree in Engineering with 5+ years in regulated manufacturing.
  • Knowledge of GMP, FDA regulations, and ISO 13485.
  • Experience with CMMS and maintenance planning.
  • Familiarity with validation, calibration, and QA documentation.
  • Strong problem-solving and RCA skills in GMP settings.
  • Excellent written and spoken English; bilingual preferred.
  • Ability to manage multiple priorities in a regulated environment.
  • Experience with EHS/OSHA standards.

Responsibilities

  • Ensure reliability of GMP-critical facility systems including HVAC, electrical, water, and fire protection.
  • Develop, optimize, and sustain preventive and predictive maintenance programs via CMMS.
  • Define maintenance frequencies, job plans, and spare parts strategies.
  • Maintain compliance and audit readiness for FDA, ISO 13485, GMP, and QMS.
  • Support IQ/OQ/PQ, requalification, calibration coordination, and change control.
  • Lead root cause analyses, deviations, and CAPAs for equipment and systems.
  • Analyze CMMS data (downtime, MTBF, MTTR) to drive improvements.
  • Provide technical input for facility installs, upgrades, modifications.
  • Support EHS programs, risk assessments, and contractor oversight.
  • Collaborate with manufacturing, laboratory, and warehouse ops at TPR1 and TPR2.

Skills

GMP Compliance
Preventive & Predictive Maintenance
CMMS Systems
Root Cause Analysis
Project Management
Data Analysis
Troubleshooting
English Proficiency
Bilingual English/Spanish
Documentation
Validation & Calibration

Education

Bachelor’s Degree in Engineering

Tools

CMMS
Building Management Systems (BMS)
AutoCAD

Job description

Jobtailor, a leading life sciences employer in Puerto Rico, seeks a Facilities & Maintenance Engineer to ensure reliable GMP-critical systems across HVAC, electrical, water, and fire protection. You will design and implement maintenance programs, optimize CMMS workflows, and support validation activities in a regulated manufacturing environment.

The role requires a bachelor’s in engineering and at least 5 years of experience in regulated manufacturing, with strong problem-solving, documentation,

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