Maintenance & Facilities Engineer
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Key Responsibilities
& Expertise
• Lead the maintenance, reliability, and lifecycle management of manufacturing equipment, facilities, mechanical and electromechanical systems, and plant infrastructure, ensuring operational readiness and maximum equipment efficiency.
• Supervise and coordinate Facilities & Maintenance Technicians, contractors, and external service providers, establishing priorities, technical direction, training, and performance expectations.
• Develop and execute preventive and corrective maintenance strategies to improve equipment.
• Ensure facilities and production equipment comply with applicable FDA, ISO, Quality System, Environmental, Health & Safety, and medical device regulatory requirements.
• Lead and support equipment qualification and validation, including URS, IQ, OQ, PQ, engineering studies, process qualification, software verification and validation, and technical validation reports.
• Partner with Engineering and suppliers on equipment selection, acquisition, installation, commissioning, qualification, and process transfer activities.
• Execute and support capital investment projects, developing business justification for equipment acquisition, replacement, upgrades, and facility improvements.
• Establish and maintain critical spare-parts programs to minimize equipment downtime and maintain manufacturing continuity.
• Manage contractors and suppliers across HVAC, electrical, plumbing, custodial services, landscaping, security, pest control, fire protection, roofing, painting, and general facility services.
• Identify and implement continuous improvement and cost-reduction opportunities focused on equipment reliability, quality, productivity, labor, materials, energy consumption, and operating costs. Education &
Experience:
Bachelor’s degree in engineering area: Mechanical, Electrical, Industrial Maintenance or Electromechanical and a minimum of 3 years related experience.
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