Apply on Employer Site

FUJIFILM Biotechnologies · 7 hours ago

Engineer 3, Clean Utilities

Holly Springs, NC

Full-time

Onsite

Senior Level

5+ years exp

FUJIFILM Biotechnologies is seeking a Clean Utilities Engineer to provide engineering support for maintenance and operational tasks related to Clean Utilities. The role involves collaborating with other Utility Engineers, ensuring compliance with safety and regulatory standards, and troubleshooting equipment issues to maintain plant reliability.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

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

Qualification

CGMP knowledgeProcess utility experienceEngineering degreeMicrosoft Office proficiencyTroubleshooting skillsEffective communicationPresentation skillsFeedback willingness

Required

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

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

Preferred

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

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)