Maintenance Mechanic

Job Summary

 HOURS - 3:00PM - 1:30AM

The Maintenance Mechanic will be responsible for maintaining manufacturing, filling equipment, facilities and utilities following Standard Operating Procedure. Under the direction of the Facilities and Maintenance Manager, the Maintenance Mechanic will support operations and other departments for day-to-day manufacturing activities working within classified areas on a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include maintenance of HVAC, Water System, Manufacturing and Filling Equipment. 

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)

• Responsible for maintaining all manufacturing equipment including formulation, filling and packaging equipment, and plant utility systems including boilers, air compressors, heating, ventilation and air conditioning systems (HVAC), Water for Injection (WFI), and general upkeep of the physical plant including clean rooms.

• Perform manufacturing and facility equipment maintenance, installations and repairs as needed including but not limited to electrical, plumbing, and light construction.

• Assist with development and documentation of preventative maintenance and calibration program for production equipment including clean room and utilities.

• Document preventive maintenance, reactive maintenance and calibration events on company deployed computerized maintenance management system (CMMS).

• Coordinate services with outside vendors for calibration and routine maintenance.

• Perform execution of equipment installation and qualification.

• Deploy 5S strategies in the setting up and maintenance of spare parts inventory utilizing CMMS software.

• Monitor facilities and manufacturing operating equipment daily, troubleshooting problems and inefficiencies and recommending possible solutions.

• Supports continuous improvement by completing work on time, identifying potential issues, and driving to improve work processes and procedures relative to manufacturing and/or filling and packaging equipment.

• Provide after-hours support and/or weekend emergency service.

• Perform continuous training assignments within the allotted time schedule.

Qualifications & Requirements

• Must have experience in a cGMP regulated environment and have worked in a medical device or pharmaceutical manufacturing facility.

• Minimum of 2 - 3 years previous experience in a medical device or pharmaceutical manufacturing preferably in a clean room environment.

• Must be familiar with machine controls including Programmable Logic Controllers (PLCs), relay logic, and operator interfaces.

• Must be comfortable working on and troubleshooting low voltage (DC) as well as high voltage (120VAC) systems.

• Must be familiar with plant utility systems compressors and HVAC.

• Strong technical ability and mechanical aptitude to troubleshoot and repair equipment malfunctions.

• Must be able to provide after-hours support and/or weekend emergency service support.

• Demonstrated ability to effectively maintain, troubleshoot, and repair industrial equipment involving technical and mechanical issues (i.e. equipment adjustments, parts replacement).

• Requires a demonstrated mechanical and technical aptitude in order to problem-solve effectively.

• Ability and willingness to work and participate effectively in a team environment. 

• Ability and willingness to maintain accurate and factual hard copy and electronic records.

• Attention to detail, safety, quality and customer requirements.

• Ability to effectively communicate verbally and in writing to peers and management.

• Ability to read information and apply what is described in the reading material to situations that may contain several details or describe processes involving several steps.

• Demonstrate high level of personal motivation and initiative.

Position Type 

• On-Site

Travel

• None