Utility Maintenance Manager - GMP Pharmaceutical Manufacturing

Nephron Pharmaceuticals Corp•West Columbia, SC

43d

About The Position

The Utility Maintenance Manager is responsible for the routine and preventive maintenance of critical utility systems supporting pharmaceutical manufacturing. The role ensures all utility equipment operates reliably, efficiently, and in compliance with GMP standards and regulatory requirements.

Requirements

Proficiency in reading P&IDs, electrical schematics, and utility system layouts.
Experience with CMMS (Computerized Maintenance Management Systems).
Knowledge of clean utility system operation and troubleshooting.
Ability to handle contending priorities and managing partner expectations.
Strong troubleshooting and mechanical aptitude.
Attention to detail and documentation accuracy.
Good communication and teamwork skills.
Ability to work independently and prioritize tasks under pressure.
Diploma or degree in Mechanical, Electrical, or Industrial Engineering, or relevant technical field.
2-5 years of experience in pharmaceutical or regulated utility system maintenance.
Strong understanding of GMP and pharmaceutical manufacturing environments.
HVAC Certification, Boiler License, or Water System Operation certifications.
GMP/GDP compliance training.

Responsibilities

Perform preventive and corrective maintenance on utility systems including:
HVAC and cleanroom environmental systems
Purified Water (PW) / Water for Injection (WFI) systems
Clean steam generators and distribution
Compressed air and gas systems (Nitrogen, CO2, etc.)
Boilers and chillers
Conduct routine inspections, monitoring, and performance checks on utility systems.
Maintain accurate maintenance logs, calibration records, and ensure data integrity in all documentation.
Support utility system qualification/validation activities (IQ, OQ, PQ).
Follow established Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP).
Assist with deviation investigations, change control, and CAPA implementation related to utility systems.
Work collaboratively with manufacturing, quality assurance, and validation teams to support production needs.
Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines
Identify and recommend improvements to increase utility system reliability and performance.
Participate in training, internal audits, and cross-functional team initiatives.
All other necessary duties required of the position or requested by Management.
Performs other similar duties as required.