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.
• Ensure all maintenance work in production areas is followed by proper cleaning and line clearance before production resumes.
• 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.
• Support internal audits and FDA inspections by providing maintenance and calibration records as requested.

Facility and Building Maintenance
• Perform general building maintenance including painting, drywall repair, flooring repair, plumbing fixtures, door hardware, lighting, and electrical outlets.
• Maintain exterior areas including parking lot, loading dock, signage, and fencing as needed.
• Coordinate with external contractors for specialized facility work (roofing, major electrical, fire system inspection, pest control).
• Ensure the facility remains in clean, safe, and audit-ready condition at all times.

Qualifications
Required
• High school diploma or GED equivalent. Trade school, vocational certificate, or associate’s degree in industrial maintenance, mechatronics, electrical technology, or a related field is strongly preferred.
• 1-2 years experience maintaining tablet presses, capsule filling machines, blister packaging machines, V-blenders, or similar pharmaceutical/nutraceutical equipment.
• Minimum 3 years of hands-on maintenance experience in a manufacturing environment, preferably pharmaceutical, nutraceutical, food, or dietary supplement manufacturing.
• Demonstrated skills in mechanical, electrical (up to 480V 3-phase), pneumatic, and basic hydraulic systems.
• Experience with preventive maintenance programs and CMMS (Computerized Maintenance Management Systems).
• Ability to read and interpret technical manuals, schematics, wiring diagrams, and engineering drawings.
• Working knowledge of OSHA safety standards including lockout/tagout (LOTO), confined space, hot work, and electrical safety.
• Proficiency with hand tools, power tools, multimeters, and diagnostic instruments.
• Strong troubleshooting and problem-solving skills with the ability to work independently under pressure.
• Ability to lift up to 75 lbs., climb ladders, work in confined spaces, and perform physical tasks throughout the shift.
 • Must pass a pre-employment drug test and be subject to random, post-incident, and reasonable suspicion testing.

 Preferred
• Experience working in an FDA-regulated (cGMP) facility with knowledge of 21 CFR Part 111.
• Experience with equipment qualification (IQ/OQ/PQ) and calibration programs.
• EPA 608 certification (for HVAC/refrigerant handling). • Welding and fabrication skills (MIG, TIG, or stick).
• PLC troubleshooting experience (Allen-Bradley, Siemens, or similar).
• OSHA 10 or OSHA 30 certification.
• Bilingual (English/Spanish) is a plus.

 Physical Requirements and Working Conditions 
• Heavy physical work including standing, walking, climbing, crouching, kneeling, and lifting up to 75 lbs throughout the shift. 
• Work at heights (ladders, rooftop equipment), in confined spaces, and in various environmental conditions. 
• Exposure to moving mechanical parts, electrical hazards, chemicals, solvents, lubricants, noise, dust, and temperature extremes. 
• Full PPE required and provided, including steel-toe boots, safety glasses, gloves, hearing protection, and respirator as warranted by specific tasks. 
• Must be medically cleared and fit-tested for respirator use. 
• On-call availability may be required to respond to emergency equipment failures or facility issues outside normal business hours. 
• Occasional weekend or extended-hour work may be required to perform maintenance during scheduled production downtime.