Engineer 2, Instrumentation & Controls

Position Overview

The I&C Engineer provides engineering support to field personnel in the performance of maintenance and operational tasks associated with instrumentation and automation systems and controls across the campus. The I&C Engineer provides support for the metrology department through evaluations of instrument deficiencies, test equipment issues and calibration strategies and methods. 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: ;br>
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
Assists in the development of Project Change Controls (PCCs) to document specific changes to the design of systems within assigned discipline
Assists with deviations and change controls resolutions and closures, as needed
Coordinates 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 standard engineering technical support for all plant utilities and systems (e.g., plant steam boilers, cooling systems, compressed air, etc.)
Partners with Senior Engineers to review and approve Preventative Maintenance templates for equipment within assigned discipline
Collaborates with Utility Operators and Maintenance Technicians to resolve operational issues
Supports the development of User Requirement Specs, Standard Operating Procedures (SOPs) and equipment maintenance and troubleshooting
Provides support for the implementation of maintenance strategies to maximize equipment reliability in conjunction with Senior Engineers
Performs standard troubleshooting for equipment challenges
Cross-trains on multiple disciplines to assist team with achieving deliverables
Collaborates with other departments (e.g., Utility Operations, Facilities, Environmental Health & Safety)
Other duties, as assigned

Knowledge & 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

Required Skills

Bachelor's Degree in Engineering with 2 years of experience with process utility related components and systems
Experience working in a Good Manufacturing Practices (GMP)…