Engineer 3, HVAC

Fujifilm•Holly Springs, NC

21h

About The Position

The HVAC Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with air handling systems for building environmental control as well as GMP clean rooms. The HVAC Engineer provides support for cold rooms and freezers on site working with other discipline engineers and HVAC technicians. 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. Company Overview FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Requirements

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

Nice To Haves

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

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