Maintenance Manager Job at Catalyx, Gaithersburg, MD

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  • Catalyx
  • Gaithersburg, MD

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.

 

Job Tags

Permanent employment,

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