Lead Maintenance Technician

Lead Maintenance Technician

The Lead Mechanic / Clean Room Technician is responsible for overseeing the maintenance, repair, troubleshooting, and reliability of manufacturing, packaging, and cleanroom equipment in a cGMP-regulated environment. This role serves as the primary maintenance lead for off-shift operations, coordinating maintenance activities with production schedules while ensuring equipment uptime, regulatory compliance, and operational efficiency. The position requires strong leadership skills, advanced mechanical troubleshooting expertise, and hands-on experience supporting pharmaceutical manufacturing and packaging equipment.

Key Responsibilities

• Serve as the primary maintenance contact for 2nd and 3rd shift operations, supporting daily production equipment maintenance and repair activities.
• Lead, train, mentor, and support maintenance technicians to ensure timely resolution of equipment issues and adherence to safety and quality standards.
• Perform and oversee preventive maintenance, corrective maintenance, troubleshooting, and repairs on manufacturing, packaging, cleanroom, and facility equipment.
• Diagnose and resolve complex mechanical, electrical, pneumatic, hydraulic, robotic, and automation-related issues to minimize downtime.
• Coordinate maintenance activities with production teams to align repairs and maintenance work with manufacturing schedules.
• Develop and execute preventive maintenance programs to improve equipment reliability and reduce unexpected failures.
• Conduct line equipment inspections, equipment setup, and operational readiness assessments.
• Maintain accurate maintenance records, work orders, repair logs, inspections, and compliance documentation.
• Manage spare parts inventory, maintenance tools, and equipment to ensure operational readiness.
• Perform root cause investigations, failure analysis, and implement corrective and preventive actions (CAPAs).
• Assist with deviation investigations, change controls, SOP revisions, and engineering documentation.
• Support equipment qualifications, validation activities, process improvements, and engineering projects.
• Monitor and maintain cleanroom systems, environmental controls, and facility equipment to ensure compliance with GMP and cleanroom requirements.
• Coordinate specialized repairs, equipment upgrades, and procurement activities with external vendors and service providers.
• Develop and implement cross-training programs for maintenance personnel supporting packaging, manufacturing, and cleanroom equipment.
• Program, troubleshoot, and maintain PLC-controlled equipment and process/environmental monitoring systems.
• Provide technical support for 24/6 manufacturing operations and respond to emergency maintenance situations as required.
• Ensure compliance with GMP, safety regulations, company policies, and industry standards.

Qualifications

• High School Diploma or GED required; technical training or trade certification preferred.
• 8–10 years of maintenance, mechanical, or industrial equipment repair experience, preferably in pharmaceutical, biotechnology, medical device, or manufacturing environments.
• 2–3 years of leadership, lead mechanic, or supervisory experience.
• Strong experience maintaining and troubleshooting manufacturing, packaging, and facility equipment.
• Working knowledge of mechanical, electrical, pneumatic, hydraulic, and automated control systems.
• Experience with PLC troubleshooting, automation systems, and environmental monitoring systems preferred.
• Proven experience developing and executing preventive maintenance programs.
• Familiarity with GMP regulations, cleanroom environments, and regulatory compliance requirements.
• Experience with maintenance management systems (CMMS) and Microsoft Office applications.
• Strong leadership, communication, problem-solving, and organizational skills.
• Ability to read and interpret mechanical drawings, electrical schematics, and technical manuals.

Preferred Experience

• Pharmaceutical, biotechnology, medical device, food, or regulated manufacturing experience.
• Cleanroom equipment and facility systems maintenance.
• Packaging equipment, process equipment, and automation systems.
• Validation, qualification, and engineering project support.
• Root cause analysis and CAPA implementation.

Key Skills

• Mechanical Maintenance, Advanced Troubleshooting
• Packaging Equipment Repair, Cleanroom Operations
• PLC Troubleshooting, Hydraulics & Pneumatics
• Preventive Maintenance, Root Cause Analysis
• GMP Compliance, CAPA Management
• Team Leadership & Training, CMMS Systems, Equipment Reliability
• Process Improvement, Safety & Regulatory Compliance