Job Summary
HOURS - 3:00PM - 1:30AM
The Maintenance Mechanic will maintain manufacturing, filling equipment, facilities, and utilities following Standard Operating Procedure. Under the direction of the Facilities and Maintenance Manager, supports day-to-day manufacturing activities in classified areas across production equipment and technologies. Daily responsibilities include maintenance of HVAC, Water System, Manufacturing, and Filling Equipment.
Core Responsibilities
- Ensure work complies with Safety Policies, Good Manufacturing Practices (GMP), and SOPs.
- Maintain formulation, filling, and packaging equipment, plant utilities (boilers, air compressors, heating, ventilation, and air conditioning (HVAC)), Water for Injection (WFI), and physical plant including clean rooms.
- Perform maintenance, installations, and repairs (electrical, plumbing, light construction).
- Assist in developing/documenting preventative maintenance and calibration programs for production equipment, clean room, and utilities.
- Document preventive, reactive, and calibration events in the CMMS.
- Coordinate vendor services for calibration and routine maintenance.
- Execute equipment installation and qualification.
- Use 5S to maintain spare parts inventory via CMMS.
- Monitor equipment daily; troubleshoot inefficiencies and recommend solutions.
- Support continuous improvement for manufacturing/filling/packaging processes.
- Provide after-hours support and/or weekend emergency service.
- Complete training assignments.
Qualifications & Requirements
- Experience in a cGMP-regulated environment; medical device or pharmaceutical manufacturing facility experience.
- 2β3 years of related experience, preferably in clean room environments.
- Familiarity with machine controls (PLCs, relay logic, operator interfaces).
- Ability to troubleshoot low voltage (DC) and high voltage (120VAC).
- Familiarity with plant utility systems, compressors, and HVAC.
- Strong mechanical/technical aptitude to troubleshoot and repair.
- Ability to provide after-hours/weekend emergency support.
- Ability to maintain accurate hard copy and electronic records.
- Attention to detail, safety, quality, and customer requirements.
- Effective verbal and written communication.
- Ability to read and apply multi-step process information.
- Motivated, team-oriented, and initiative-driven.
Position Type: On-Site
Travel: None