Engineer 3, Clean Utilities

Merck & Co.; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

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

Position Overview

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

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.