Engineer 3 Clean Utilities

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.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine cure or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion energy and drive what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a newlargescale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll 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
• Crosstrains 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

• Bachelors 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 viaemail 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.

Fujifilm is committedto providing equal opportunities in hiring promotion and advancement compensation benefits and training regardless of nationality age gender sexual orientation or gender identity race ethnicity religion political creed ideology national or social origin disability veteran status etc.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .