Utility Maintenance Manager - GMP Pharmaceutical Manufacturing

Description

Corporate Statement:

Nephron Pharmaceuticals is a privately-owned global leader in the manufacturing of generic drug products, over-the-counter (OTC) drug products and medical devices. Nephron’s products are sterile, preservative and additive free and proudly made in the USA! We are headquartered in West Columbia, South Carolina. Our location provides the ability to develop new devices and medications including respiratory therapies, ophthalmic, and injectables, for in-house or contract manufacturing opportunities. The facility utilizes completely automated manufacturing, packaging, and distribution systems, in addition to high volume and redundant utility systems, to ensure production system availability. Nephron specializes in Blow-Fill-Seal (BFS) manufacturing, a niche technology that allows a vial of medication to be formed, filled and sealed in a continuous process, in a sterile, enclosed environment and without human intervention.

As an industry leader in product safety and quality, Nephron produces a variety of inhalation solutions, and has distributed over 1 billion doses of respiratory medication per year since 2009. The company’s longstanding relationships with major drug wholesalers allow us to distribute our products to retail pharmacies, mail order pharmacies, hospitals, home care companies, and long-term care facilities. Nephron has a sales force that covers all fifty states and some international territories. Nephron exists to provide top-quality, affordable medications to everyone. Our quality first culture is built on: Transformation, Execution and Trust.

Job Purpose:

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.

Essential Duties and Responsibilities:

Ø Perform preventive and corrective maintenance on utility systems including:

Ø HVAC and cleanroom environmental systems

Ø Purified Water (PW) / Water for Injection (WFI) systems

Ø Clean steam generators and distribution

Ø Compressed air and gas systems (Nitrogen, CO2, etc.)

Ø Boilers and chillers

Ø Conduct routine inspections, monitoring, and performance checks on utility systems.

Ø Maintain accurate maintenance logs, calibration records, and ensure data integrity in all documentation.

Ø Support utility system qualification/validation activities (IQ, OQ, PQ).

Ø Follow established Standard Operating Procedures (SOPs) and Good Documentation Practices (GDP).

Ø Assist with deviation investigations, change control, and CAPA implementation related to utility systems.

Ø Work collaboratively with manufacturing, quality assurance, and validation teams to support production needs.

Ø Ensure compliance with cGMP, FDA, EMA, and other regulatory guidelines

Ø Identify and recommend improvements to increase utility system reliability and performance.

Ø Participate in training, internal audits, and cross-functional team initiatives.

Ø All other necessary duties required of the position or requested by Management.

Supplemental Functions: 

Ø Performs other similar duties as required.

Job Specifications and Qualifications: 

Technical Skills:

Ø Proficiency in reading P&IDs, electrical schematics, and utility system layouts.

Ø Experience with CMMS (Computerized Maintenance Management Systems).

Ø Knowledge of clean utility system operation and troubleshooting.

Abilities:

Ø Ability to handle contending priorities and managing partner expectations.

Ø Strong troubleshooting and mechanical aptitude.

Ø Attention to detail and documentation accuracy.

Ø Good communication and teamwork skills.

Ø Ability to work independently and prioritize tasks under pressure.

Education/Experience: 

Ø Diploma or degree in Mechanical, Electrical, or Industrial Engineering, or relevant technical field.

Ø 2–5 years of experience in pharmaceutical or regulated utility system maintenance.

Ø Strong understanding of GMP and pharmaceutical manufacturing environments.

Licensing and Certifications:

Ø HVAC Certification, Boiler License, or Water System Operation certifica