Maintenance Sr Technician - GMP - 2nd Shift

About the

Role:

As a GMP Facilities Maintenance Technician, you'll be crucial in ensuring the operational integrity and regulatory compliance of a cGMP (current Good Manufacturing Practice) production facility. You will be responsible for the maintenance, repair, and calibration of industrial systems, utilities, and equipment essential for manufacturing in a controlled environment. This position is a key part of our Engineering and Technical Services team, directly contributing to the quality and reliability of our manufacturing processes by providing expert support, preventive maintenance, and corrective repairs on critical systems.

What You'll Do:

Perform scheduled preventive maintenance (PMs) and corrective repairs on a wide range of mechanical, electrical, and utility systems, including HVAC, purified water systems, and compressed air. Conduct routine inspections and calibrations of equipment to ensure compliance with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (GMP). Troubleshoot and diagnose potential issues with equipment and utility systems, implementing timely and effective repairs to minimize downtime. Assist with the installation, qualification, and modification of new or existing facility equipment and systems, following strict change control procedures. Review and complete work orders using a Computerized Maintenance Management System (CMMS), ensuring all work is properly documented for audit readiness. Support root cause analysis (RCA) for equipment failures or deviations, proposing and implementing corrective and preventive actions (CAPA). Ensure all maintenance activities comply with regulatory requirements, FDA guidelines, and internal quality standards. Maintain a safe and organized work environment, adhering to all safety protocols, including Lockout/Tagout (LOTO) procedures.

What You'll Need:

A High School Diploma, GED, or trade school diploma with 1-2 years of job-related experience. Experience in a controlled environment or cleanroom setting is a plus, but not required. Minimum 2 years' experience in a GMP, pharmaceutical, biotechnology, or medical device manufacturing environment required. Proficiency in reading and interpreting schematics, blueprints, and equipment manuals. Strong mechanical and electrical aptitude, with a working knowledge of industrial equipment and building systems. Experience with a CMMS for work order management and documentation. Ability to meet the physical demands of the role, including stooping, standing, climbing stairs/ladders, and lifting/carrying heavy loads of 50 lbs. or more. Excellent communication and documentation skills, with attention to detail required for maintaining accurate records in a regulated environment.