Operations and Maintenance Engineer

hace 4 días


San Francisco, Heredia, Costa Rica Viant Medical A tiempo completo
Job Description

The Facilities Engineer will play a pivotal role in ensuring the smooth operation of our manufacturing facilities. As part of our team, you will be responsible for developing and implementing preventive and corrective maintenance strategies for equipment and machinery.

This role requires strong leadership skills, as you will oversee the performance of technicians and coordinate with the Facilities Manager to design, plan, and maintain equipment, buildings, and other facilities.

You will also be responsible for controlling and documenting official department functions, supporting new product introductions, and ensuring compliance with FDA regulations.

Main Responsibilities:

  • Implement Good Manufacturing Practices (GMPs) to ensure regulatory compliance.
  • Evaluate and improve preventive maintenance tasks to ensure high equipment reliability.
  • Supervise and guide technicians to ensure proper building and cleanroom operations.
  • Participate in achieving departmental goals and objectives.
  • Analyze operational excursions, NCEs, CAPAs, and exceptions documents.
  • Manage contractors and consultants, lead projects, and implement them.
  • Ensure life/safety systems are operable at all times.
  • Model EHS program implementation in all activities.
  • Lead or participate in continuous improvement teams.
  • Establish indicators of facilities and manufacturing equipment operation.
  • Analyze, propose, and implement plans to improve continuously.
  • Develop and find new suppliers and contractors.
  • Define, inventory, and coordinate spare parts.
  • Perform project management responsibilities for assigned maintenance changes or new product launch.
  • Maintain good relationships with Production, Quality, and Supply Chain people.
  • Recommend new tools and methodologies, including costing and cost estimates.
  • Develop or revise technical documentation.
  • Conduct research and development testing and validation.
  • Negotiate and place orders with vendors.
  • Attend conferences, take courses, and continue education programs.

Requirements:

  • Bachelor's degree in Mechanical, Electrical, or Electromechanical Engineering.
  • Bilingual (Intermediate level of Spanish and English).
  • Knowledge on ISO 13485:2003 and CFR 820 CGMPs.
  • Familiarity with computer packages, including Autocad and Project Management.
  • Problem-solving preparation.
  • At least 5 years of experience as a Facilities Engineer or Maintenance Engineer.
  • Leadership experience as a technician leader.
  • Knowledge in EHS field.
  • Project management knowledge.

Estimated Salary Range: $80,000 - $110,000 per year, depending on location and experience.



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