Maintenance Specialist

Responsibilities

• Oversee and perform inspections, maintenance, and repairs on all facility equipment, including HVAC systems, Water-For-Injection (WFI) systems, compressed gases, refrigeration units, plumbing, electrical and mechanical systems, as well as plant steam, chilled water systems, and laboratory instruments.
• Manage preventive maintenance and calibration schedules using a Computerized Maintenance Management System (CMMS) to ensure optimal equipment performance.
• Address and resolve operational issues that arise in plant systems, ensuring minimal disruptions to facility processes.
• Schedule and execute routine preventative maintenance and calibration tasks, providing prompt responses to minimize system downtime.
• Diagnose and troubleshoot malfunctions in instrumentation and equipment, carrying out corrective maintenance as necessary.
• Collaborate with internal departments and equipment vendors to establish appropriate calibration and maintenance intervals and specifications.
• Accurately document all calibration, maintenance, and repair activities to ensure compliance with industry standards and reflect the scope of work performed.
• Support modifications, installations, commissioning, and validation processes for new equipment or instruments, as well as decommissioning outdated systems.
• Assist in planning and managing the department's budget for calibration and maintenance needs.
• Contribute to the spare parts program by determining appropriate inventory levels, ensuring availability to reduce downtime.
• Be flexible to work varied hours, including overtime or responding to after-hours alarms, to ensure continuous production coverage.

Qualifications

• High school diploma with technical or equivalent military training.
• Minimum of 5 years of experience in troubleshooting, maintaining, and calibrating system instruments within an operational or manufacturing environment.
• Ability to work overtime and respond to after-hours alarms, including weekends and holidays.
• Proficient in the use of Computerized Maintenance Management Systems (CMMS).
• Experience working within cGMP-compliant pharmaceutical and device manufacturing environments.
• Previous experience in a sterile pharmaceutical manufacturing facility is highly preferred.