Clean Utilities Engineer

Technical Source is hiring a Clean Utilities Engineer for our large pharmaceutical manufacturing client in Sanford, NC. The ideal candidate will have experience owning, maintaining, and optimizing clean utility systems at a GMP facility.

Key Responsibilities

• Own and support clean utilities systems:

  • Purified Water (PW)
  • Water for Injection (WFI)
  • Clean steam
  • Pharmaceutical/oil-free compressed air
  • Process gases and associated distribution/ancillary systems

• Troubleshooting & investigations

  • Monitor system performance and respond to excursions or failures
  • Perform root cause analysis, particularly for contamination- or quality-related events
  • Implement corrective and preventive actions with Maintenance, Reliability, and Operations

• Quality & documentation ownership

  • Initiate and manage change controls
  • Lead or own deviations and investigations
  • Develop and execute CAPAs
  • Write and revise SOPs and technical procedures
  • Support inspection readiness for clean utilities

• Project support

  • Support projects aimed at:
    • Improving efficiency and reliability of clean utilities
    • Reducing contamination-related deviations

• Collaboration

  • Work closely with the Sr. Utilities Engineer and cross-functional teams: Operations, Maintenance, Reliability, QA, QC Micro, EHS, and Project Engineering

Required Background

• Experience: 5–10 years in utilities, facilities, plant, or maintenance engineering
• Industry:
  • Preferred: pharmaceutical/biotech manufacturing
  • Also considered: OEMs/design firms or other industries using clean/high-purity utilities (e.g., PW/WFI-like, clean steam, high-purity compressed air/gases)

Must-Have Skills:

• Hands-on experience with clean or high-purity utilities such as PW, WFI, clean steam, compressed air, and/or process gases
• Proven troubleshooting and root cause analysis experience on utility or facility systems
• Experience in GMP or a similar structured quality system, including:
  • Change control
  • Deviations/investigations
  • CAPAs
  • SOP writing/revision

Tools:

• Experience with a CMMS (any platform; client uses EAMS)
• Standard computer skills (Office); CAD/SolidWorks/MS Project are a plus

Work Environment & Schedule

• Onsite at a major aseptic pharmaceutical manufacturing facility in Rocky Mount, NC
• Standard day shift
• No formal on-call rotation
• Must be willing to work during planned shutdowns (may occur evenings/weekends)
• Mix of office, plant floor, mechanical spaces, and outdoor areas; PPE use and ability to use stairs/ladders required