Senior Clean Utilities Engineer (RO/EDI, WFI)

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

FUJIFILM Biotechnologies seeks a Clean Utilities Engineer 3 to support RO/EDI skids, WFI, WPU, clean gases and waste systems. You will work with Senior Utility Engineers to ensure safety, regulatory compliance, and reliable operation of on-site utilities.

You’ll develop change controls, deviations, and maintenance strategies, troubleshoot equipment issues, and support GMP-compliant processes. Collaboration with operators, maintenance, and facilities teams is essential.

Qualifications

• Bachelor’s degree in engineering with 5 years of process-utility experience.
• Experience in GMP or other highly regulated environments.

Responsibilities

• Coordinate with Senior Utility Engineers to ensure deliverables meet company standards.
• Develop PCCs for changes to system designs.
• Prepare deviations, change control resolutions, and closures.
• Review submittals, installation, and testing of equipment.
• Perform field walkdowns to verify installation per standards.
• Provide engineering support for plant utilities and systems.
• Review and approve PM templates for equipment.
• Collaborate with Operators and Maintenance Technicians to resolve issues.
• Develop URS, SOPs, and maintenance procedures.
• Support maintenance strategies to maximize reliability; ensure GMP compliance.
• Participate in audits with customers/regulatory agencies.
• Cross-train across disciplines.

Skills

cGMP knowledge

Regulatory knowledge

MS Office

Troubleshooting

Communication

Presentation

Education

Bachelor's in Engineering

Tools

Microsoft Office

SharePoint

Job description

FUJIFILM Biotechnologies seeks a Clean Utilities Engineer 3 to support RO/EDI skids, WFI, WPU, clean gases and waste systems. You will work with Senior Utility Engineers to ensure safety, regulatory compliance, and reliable operation of on-site utilities.

You’ll develop change controls, deviations, and maintenance strategies, troubleshoot equipment issues, and support GMP-compliant processes. Collaboration with operators, maintenance, and facilities teams is essential.