Engineer , Clean Utilities

Engineer 3, Clean Utilities – FUJIFILM Biotechnologies

The Clean Utilities Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with Clean Utilities, including reverse osmosis/electrode ionization (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 include supporting deviation investigations and documentation for associated system deficiencies.

• 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

• 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 analyze and troubleshoot simple to moderate system and component related issues
• Ability to effectively present information to others
• Willingness to provide feedback to others, including leaders

• 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

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

PHYSICAL DEMANDS

Will work in environment which may necessitate respiratory protection.

Will work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

Will work in environment operating a motor vehicle or Powered Industrial Truck.

Ability to discern audible cues.

Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.

Ability to ascend or descend ladders, scaffolding, ramps, etc.

Ability to stand for prolonged periods of time.

Ability to sit for prolonged periods of time.

Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.

Ability to operate…