What are the responsibilities and job description for the Facilities Maintenance Technician II position at GBI Bio?
Description
The Facilities Maintenance Technician II is responsible for executing preventive and corrective maintenance activities on facility systems and manufacturing equipment within a regulated biotech environment. This role operates with a moderate level of independence, supporting GMP operations by ensuring equipment reliability, timely response to critical alarms, and compliance with FDA regulations and internal quality systems. The technician will coordinate with external vendors, support system lifecycle activities, and ensure all work is accurately documented to maintain a state of inspection readiness.
Key Responsibilities
The Facilities Maintenance Technician II is responsible for executing preventive and corrective maintenance activities on facility systems and manufacturing equipment within a regulated biotech environment. This role operates with a moderate level of independence, supporting GMP operations by ensuring equipment reliability, timely response to critical alarms, and compliance with FDA regulations and internal quality systems. The technician will coordinate with external vendors, support system lifecycle activities, and ensure all work is accurately documented to maintain a state of inspection readiness.
Key Responsibilities
- Conduct daily walk-throughs to very the operational condition of critical areas and equipment.
- Perform scheduled preventive maintenance (PM) and corrective maintenance on facility systems and production equipment with minimal supervision.
- Ensure materials, consumables and spare parts are prepared in advance to allow PMs to be undertaken in accordance with the monthly PM plan and the annual shutdown plan.
- Troubleshoot and repair mechanical, electrical, and HVAC systems, including GMP utilities (e.g., compressed air, purified water, environmental monitoring systems).
- Independently monitor, review, and respond to REES alarms, including temperature, humidity, and critical equipment alerts.
- Conduct initial alarm assessments, implement corrective actions, and escalate issues in accordance with established. procedures.
- Coordinate and oversee work performed by external vendors, including calibrations, preventative maintenance, and repairs.
- Support equipment installation, commissioning, qualification, and decommissioning activities.
- Respond to equipment failures and facility issues promptly to minimize operational impact.
- Adhere to all safety requirements, including lockout/tagout (LOTO) and OSHA regulations.
- Participate in internal and external audits by providing documentation and technical support.
- Support facility construction activities.
- Identify and implement opportunities for continuous improvement in maintenance practices, alarm response, and equipment performance
- Collaborate effectively with Manufacturing, Quality, and Engineering to support production objectives.
- Technical degree in Mechanical, Electrical, Industrial Maintenance.
- 5 years of relevant maintenance experience in a regulated environment (biotech, pharmaceutical, or medical device manufacturing preferred)
- Working knowledge of GMP regulations, FDA requirements, and documentation practices
- Experience with environmental monitoring and alarm systems (e.g., REES or similar)
- Proficiency with CMMS platforms (e.g., MasterControl or equivalent)
- Ability to interpret technical drawings, schematics, and SOPs
- Familiarity with cleanroom operations and controlled environments
- Ability to lift up to 50 lbs
- Ability to work in controlled environments, including cleanrooms
- Biotech manufacturing facility operating under GMP conditions
- May require occasional after-hours or weekend support for maintenance activities