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Facilities Validation Engineer

Gurabo, PR
FACILITIES VALIDATION ENGINEER
 
Description

We are seeking a Facilities Validation Engineer to operate assigned equipment, facility and utilities in accordance with established guidelines and operating procedures. Conduct basic troubleshooting and employ basic predictive technologies to identify root cause and appropriate corrective actions for equipment problems or to diagnose equipment problems. Execute intermediate maintenance activities or operates and monitors plant support equipment. The candidate must have solid GMP and regulatory experience.

Duties and Responsibilities
  • Maintain an up-to-date working spare parts inventory system for the equipment and systems.
  • Ensure that operational log files, and work order documentation is completed. 
  • Utilities, Maintenance, and Troubleshooting knowledge of equipment.
  • Facilities & warehouse qualification/commissioning.
  • Develop, revise, and review related SOPs or job plans/work plans for work related areas. Assist in the evaluation of the current utilities procedures and recommend changes to optimize the utilities program. 
Skills and Specifications
  • Knowledge of Utility Plant Operations, Maintenance, Process Equipment, System Maintenance, HVAC systems & troubleshooting.
  • Candidates must have flexibility to support processes in various shifts and workdays per the operational needs. 
  • Experience in facilities & utilities qualification/commissioning 
  • Building Management System Operational Knowledge.
  • Familiarity with basic Cleanroom, Fume Hood, Biological Safety Cabinet, and Unidirectional Flow Hood systems.
  • Knowledge of Temperature / Relative Humidity 
  • Knowledge of warehouse qualification 
  • Experience with Templates
  • Bilingual (English and Spanish)
Experience
  • Minimum of five years of experience in a related role within the pharmaceutical / Medical Device manufacturing industry required.
Education
               
             Bachelor’s in engineering (BSME, BSEE, BSChE, BSIE preferred)

Additional requirements
  • Problem Solving 
  • Sense of urgency 
  • Detail Oriented 
  • Be flexible enough to travel to job sites when need arises. 
  • Able to work with minimum or no supervision 
  • Strong interpersonal skills and must work in a team.
Ultimate Solutions Corp is an Equal Opportunity Employer.

 
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