Maintenance Technician

Job Description

Job Description

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.
• 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.