Lead Mechanic / Clean Room Technician- Parsippany NJ- 2^nd shift- 3pm to 11:30pm
Position Summary
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

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