Engineer 3, Clean Utilities

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

The Clean Utilities Engineer 3 provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrodeionization (RO/EDI) skids, water for injection (WFI), purified water (WPU), Clean gasses and applicable waste systems. This role works directly with other Utility Engineers ensuring applicable safety and regulatory standards are maintained, identifies process improvements, and assists with troubleshooting equipment issues to maintain overall plant reliability. Additional responsibilities includes supporting deviation investigations and documentation for associated system deficiencies.

Job Description

What You’ll Do

• Coordinates with Senior Utility Engineers within assigned discipline to ensure project deliverables (e.g., specification review, Factory Acceptance Tests (FATs) and visits, equipment installation, and issue resolution) are performed to the company standards
• Develops Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
• Prepares deviations and change control resolutions and closures
• Performs reviews of submittals, installation, and testing of equipment within assigned discipline across all buildings on site
• Performs field walkdowns with Utility Engineering and Construction personnel to ensure systems are installed per approved standards and drawings
• Provides engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
• Reviews and approves Preventative Maintenance templates for equipment within assigned discipline
• Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues
• Develops or provides supports in the development of User Requirement Specs (URSs), Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting procedures
• Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers
• Maintains Good Manufacturing Practices (GMP) compliance aspects of validated systems
• Participates in audits with customer representatives and regulatory agencies, as needed
• Performs simple to moderate troubleshooting for equipment challenges and supports Senior Engineers with complex troubleshooting
• Cross-trains within multiple disciplines to assist team with achieving deliverables
• Collaborates with other departments (e.g., Utility Operations, Maintenance, Facilities, Environmental Health, and Safety)
• Other duties, as assigned

Knowledge And Skills

• Effective communication, both written and verbal
• Knowledge of cGMP and European Medicines Evaluation Agency (EMEA) or Food & Drug Administration (FDA) regulations
• Proficient in Microsoft Office (e.g., Word, Excel, PowerPoint, SharePoint)
• Ability to utilize software programs related to job responsibilities
• Ability to analyze and troubleshoot system and component related issues
• Ability to effectively present information to others

Basic Requirements

• Bachelor’s Degree in Engineering with 5 years of experience with process utility related components and systems
• Experience working in a GMP or other highly regulated environment

Preferred Requirements

• Experience establishing processes and procedures for operation, troubleshooting and monitoring process utility systems

Working Conditions & Physical Requirements

Will work in environment which may necessitate respiratory protection. No X Yes

May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program. No X Yes

Will work in environment operating a motor vehicle or Powered Industrial Truck. No X Yes

Ability to discern audible cues. No X Yes

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. No X Yes

Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes

Ability to stand for prolonged periods of time. No X Yes 30 minutes

Ability to sit for prolonged periods of time. No X Yes 120 minutes

Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. X No Yes

Ability to operate machinery and/or power tools. X No Yes

Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.

Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes