Facilities Maintenance Specialist

hace 1 mes


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

Main Job Responsibilities:

The Facilities Maintenance Specialist will oversee the preventive and corrective maintenance of the Manufacturing and Facilities equipment in our site. This includes coordinating with the Facilities/Maintenance Manager on equipment design, planning, construction, and maintenance. Additionally, the specialist will supervise the performance of technicians and control official documentation related to department functions.

Main Job Duties/Responsibilities:

  • Implement and enforce Good Manufacturing Practices (GMP's) as defined by Vention's practices, policies, and Standard Operating Procedures (SOP's) to ensure FDA regulations are met.
  • Evaluate and improve preventive maintenance tasks to ensure high equipment/building operation reliability according to regulations.
  • Supervise and guide Facilities and Maintenance Technicians to ensure proper operation of all buildings and cleanrooms in the Costa Rica location.
  • Participate actively in achieving department and plant goals and objectives.
  • Analyze and resolve operational excursions, NCE's, CAPA's, and other exceptions documents in the department.
  • Additional functions may include managing contractors and consultants. This position requires the capacity to lead projects and implement them.
  • Ensure life/safety systems are operable at all times, including sprinkler systems, smoke and fire detection systems, fire extinguishers, signage, and evacuation plans, as well as fire prevention.
  • Lead or participate in continuous improvement teams of the operation.
  • Establish indicators of facilities and manufacturing equipment operation with the Facilities/Maintenance Manager and follow positive results.
  • Analyze, propose, and implement plans to improve the operation of facilities and maintenance equipment.
  • Develop and find new suppliers and contractors to support normal facilities and manufacturing equipment operation.
  • Lead the spare parts definition, inventory, and coordination in the plant to ensure necessary quantities.
  • Perform project management responsibilities for assigned maintenance changes or new product launches.
  • Maintain good relationships with Production, Quality, and Supply Chain people to provide fluency in business processes.
  • Recommend new tools and methodologies, including costing and cost estimates for design or product process changes.
  • Develop or revise technical documentation to specify maintenance and facilities processes, including documentation of equipment qualification, setup, and maintenance procedures.
  • Conduct research and development testing and validation to determine effectiveness and compliance to quality standards for manufacturing processes.
  • Negotiate and place orders with Vention's vendors, maintaining a positive and healthy relationship, avoiding conflict of interest.
  • Attend conferences, take courses, and participate in continuing education programs to maintain or improve knowledge and practices relevant to medical device manufacturing.

Knowledge/Experience Requirements:

- Bachelor's degree in Mechanical, Electrical, or Electromechanical Engineering.

- Bilingual with an intermediate level of Spanish and English.

- Knowledge of ISO 13485:2003 and CFR 820 CGMPs.

- Familiarity with computer software packages, including Autocad and Project Management.

- Problem-solving preparation.

Work Experience:

- At least 5 years of experience as a Facilities Engineer or Maintenance Engineer, preferably in a medical company.

- Leadership experience as a technician supervisor.

- Knowledge and experience in EHS (Environment, Health, and Safety) fields.

- Project management experience.



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