Facilities Maintenance Specialist
hace 1 mes
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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