The Maintenance Technician is responsible for the preventive maintenance, troubleshooting, repair, and upkeep of all manufacturing equipment, facility systems, and building fixtures at MKRS. This is a hands-on, multi-skilled role supporting continuous production operations in an FDA-regulated dietary supplement manufacturing environment. The Maintenance Technician ensures that all equipment — including tablet presses, capsule filling machines, V-blenders, blister carding machines, HVAC systems, compressed air systems, dust collection systems, scales, conveyors, and general building infrastructure — remains in safe, reliable, and cGMP-compliant operating condition. This role is critical to minimizing production downtime and maintaining the facility in audit-ready condition at all times.
Essential Duties and Responsibilities
Preventive Maintenance
• Develop, schedule, and execute a preventive maintenance (PM) program for all manufacturing equipment, facility systems, and building fixtures.
• Perform routine PM tasks including lubrication, filter changes, belt and gasket replacement, calibration support, bearing inspection, and wear-part replacement on tablet presses, capsule machines, V-blenders, blister packaging machines, and ancillary equipment.
• Maintain and service HVAC systems, compressed air systems, dust collection and ventilation systems, plumbing, and electrical systems.
• Inspect and maintain building fixtures including lighting, doors, loading docks, fire suppression equipment, eye wash stations, emergency showers, and warehouse racking.
• Maintain PM logs, schedules, and records in compliance with cGMP documentation requirements.
Troubleshooting and Repair
• Diagnose and repair mechanical, electrical, pneumatic, and hydraulic issues on production equipment, including tablet presses, capsule filling machines, blister carding machines, V-blenders, conveyors, and packaging equipment.
• Respond promptly to production floor equipment breakdowns to minimize downtime and restore operations as quickly as possible.
• Troubleshoot and repair facility systems including HVAC, refrigeration, compressed air, dust collection, plumbing, and electrical circuits.
• Read and interpret equipment manuals, technical drawings, schematics, wiring diagrams, and parts lists.
• Fabricate, modify, or adapt parts and fixtures as needed using basic shop tools, welding equipment, or machining.
• Coordinate with external service contractors and OEM representatives for specialized repairs, installations, or warranty work.
Equipment Installation and Qualification
• Assist with the installation, setup, and commissioning of new manufacturing equipment.
• Support equipment qualification activities (Installation Qualification / Operational Qualification / Performance Qualification — IQ/OQ/PQ) in coordination with the Quality Department.
• Ensure all new or modified equipment meets safety, cGMP, and operational requirements before release to production.
Calibration Support
• Support the calibration program for production instruments including scales/balances, temperature and humidity sensors, pressure gauges, and tablet hardness testers.
• Maintain calibration records and ensure instruments are calibrated on schedule per cGMP requirements.
• Coordinate with external calibration vendors as needed.
Safety and Compliance
• Perform all lockout/tagout (LOTO) procedures before working on any equipment per OSHA 29 CFR 1910.147 and MKRS SOPs.
• Follow all confined space entry, hot work permit, and electrical safety procedures as applicable.
• Wear all required PPE for specific tasks, including safety glasses, steel-toe boots, gloves, hearing protection, respirator, and arc flash protection as warranted.
• Maintain SDS awareness for all chemicals, solvents, lubricants, and cleaning agents used in maintenance activities.
• Follow cGMP requirements when working in or near production areas, including proper gowning, handwashing, and tool sanitization to prevent product contamination.
• Report any safety hazards, equipment deficiencies, or facility issues to the Production Manager immediately.
cGMP Documentation
• Complete maintenance work orders, PM logs, equipment repair records, and calibration records accurately, legibly, and contemporaneously in permanent ink.
• Document all equipment downtime, root cause analysis, and corrective actions taken.
• Maintain an organized spare parts inventory and reorder critical components before stock-out.
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