Utilities Engineer III – GMP Systems & Plant Reliability

Merck & Co.

Holly Springs (NC)

On-site

USD 90,000 - 130,000

Full time

13 days ago
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Job summary

FUJIFILM in North Carolina's Holly Springs is seeking a Clean Utilities Engineer 3 to support maintenance and operation of RO/EDI skids, WFI, WPU, clean gases and related waste systems. You will work with Utility Engineers to ensure safety and regulatory standards are met while identifying process improvements and assisting with troubleshooting to maintain plant reliability.

The role involves documenting deviations, URS/SOP development, and supporting maintenance strategies; audits with

Qualifications

  • Bachelor's Degree in Engineering with 5 years of experience in process utilities.
  • Experience in GMP or other highly regulated environments.
  • Knowledge of cGMP and FDA/EMEA regulations is preferred.

Responsibilities

  • Coordinates with Senior Utility Engineers to ensure project deliverables meet company standards.
  • Develops Project Change Controls (PCCs) for system design changes.
  • Prepares deviations and change control resolutions and closures.
  • Reviews submittals, installation, and testing of equipment within assigned discipline.
  • Collaborates with Operators and Maintenance Technicians to resolve issues.
  • Supports URS, SOP development and maintenance procedures.

Skills

Effective communication
GMP knowledge
Regulatory knowledge
Microsoft Office
Troubleshooting
Field collaboration

Education

Bachelor's Degree in Engineering

Job description

FUJIFILM in North Carolina's Holly Springs is seeking a Clean Utilities Engineer 3 to support maintenance and operation of RO/EDI skids, WFI, WPU, clean gases and related waste systems. You will work with Utility Engineers to ensure safety and regulatory standards are met while identifying process improvements and assisting with troubleshooting to maintain plant reliability.

The role involves documenting deviations, URS/SOP development, and supporting maintenance strategies; audits with

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