Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Various outside weather conditions, Warehouse, Working at heights

Job Description

DESCRIPTION:

The Manager, Process Utilities is responsible for the safe, compliant, reliable, and efficient operation of site utility systems that support manufacturing, laboratory, and facility operations. This position provides leadership and technical oversight for the Process Utilities organization, including licensed/raised-seal boiler operators, utility technicians, and other assigned personnel.

The Manager ensures critical utility systems are operated and maintained in accordance with applicable regulatory requirements, environmental and safety standards, site procedures, and established engineering practices. The role is accountable for workforce development, operational readiness, system reliability, regulatory compliance, and continuous improvement of utility operations.

**This position will report too - 1125 Pleasant View Terrace Ridgefield, NJ**

Key Responsibilities

• Provide overall leadership and technical oversight for process and clean utility systems supporting pharmaceutical manufacturing operations.
• Ensure the safe, reliable, compliant, and cost-effective operation of critical utility systems, including:
  • Purified Water (PW)
  • Water for Injection (WFI), where applicable
  • Clean Steam / Pure Steam
  • Process and Clean Compressed Air
  • Process Gases, including nitrogen and other specialty gases
  • Clean-in-Place (CIP) utility interfaces and associated distribution systems
  • Other GMP-critical process utilities supporting manufacturing, laboratory, and production areas
• Maintain utility systems in a validated and qualified state in accordance with GMP requirements, site quality systems, approved procedures, and applicable regulatory expectations.
• Serve as the system owner or technical authority for assigned process utility systems, ensuring appropriate lifecycle management, system performance, reliability, and compliance.
• Develop and execute preventive and predictive maintenance strategies to maximize utility availability, reliability, and equipment lifecycle while minimizing unplanned manufacturing interruptions.
• Monitor system performance, capacity, quality attributes, alarms, trends, and reliability metrics to proactively identify deterioration, recurring issues, and opportunities for improvement.
• Partner with Manufacturing, Engineering, Maintenance, Quality Assurance, Validation, Automation, EHS, and Facilities to ensure utility systems continuously meet operational and GMP requirements.
• Lead or support investigations involving utility excursions, equipment failures, deviations, environmental or quality events, including root cause analysis and CAPA development and implementation.
• Provide technical leadership for commissioning, qualification, and validation (CQV) activities associated with new installations, modifications, expansions, and major maintenance activities.
• Review and approve technical documentation as appropriate, including specifications, drawings, P&IDs, SOPs, maintenance procedures, qualification protocols, change controls, deviations, CAPAs, and engineering studies.
• Manage changes to GMP utility systems through established change control and quality risk management processes, ensuring impacts to product quality, validated state, operations, and regulatory compliance are appropriately assessed.
• Establish and maintain appropriate preventive maintenance, calibration, inspection, sanitization, and monitoring programs for clean utility equipment and distribution systems.
• Ensure appropriate control of critical parameters affecting utility quality, including water chemistry, microbiological control, temperature, pressure, flow, sanitization, and distribution-loop performance.
• Support regulatory and customer inspections by providing system documentation, technical expertise, investigation support, and responses related to process and clean utilities.
• Develop and maintain utility capacity and demand forecasts to support production requirements, facility expansio