Maintenance Manager

Job Description
We are seeking an experienced GxP Maintenance Manager to lead maintenance operations in a pharmaceutical manufacturing facility. The role involves ensuring compliance with GMP, FDA, EMA, and other regulatory standards while managing equipment reliability, preventive maintenance, and continuous improvement initiatives.

Key Responsibilities:

• Develop and implement GMP-compliant maintenance programs for pharmaceutical manufacturing equipment and facilities.
• Ensure regulatory compliance with FDA, EMA, GMP, and ISO guidelines.
• Manage preventive, predictive, and corrective maintenance to minimize downtime and ensure operational efficiency.
• Oversee maintenance of critical systems such as HVAC, cleanrooms, utilities, process equipment, and automation systems.
• Maintain CMMS (Computerized Maintenance Management System) to track maintenance activities and ensure proper documentation.
• Lead, train, and develop the maintenance team to ensure adherence to GxP and safety protocols.
• Support equipment validation (IQ/OQ/PQ), calibration, and qualification efforts.
• Collaborate with Quality Assurance, Engineering, and Production teams to enhance reliability and compliance.
• Prepare for and support regulatory inspections and audits.

Requirements

Requirements:

• Bachelor's degree in Engineering, Facilities Management, or a related field.
• 5+ years of maintenance management experience in a GMP-regulated pharmaceutical environment.
• Strong knowledge of GMP, FDA regulations, validation protocols, and aseptic manufacturing.
• Experience with automation, process controls, HVAC, and critical utilities.
• Proficiency in CMMS, Root Cause Analysis (RCA), and continuous improvement methodologies.
• Excellent leadership, problem-solving, and communication skills.