Engineer 2, Instrumentation & Controls

FUJIFILM Healthcare Americas Corporation; Holly Springs (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

FUJIFILM Healthcare Americas Corporation in Holly Springs, NC seeks an I&C Engineer to support maintenance and operation of instrumentation, automation, and metrology activities across the campus. You will coordinate with senior utilities engineers, assist with change controls, and troubleshoot equipment to maximize plant reliability.

You will collaborate with operators and maintenance teams to develop SOPs and maintenance strategies while ensuring cGMP compliance and safety standards are met

Qualifications

• Bachelor's Degree in Engineering with 2 years of experience in process utility components.
• Experience working in GMP or other highly regulated environments.

Responsibilities

• Coordinate with Senior Utility Engineers to meet project deliverables.
• Assist in PCC development and change controls resolution.
• Review submittals, installation, and testing of equipment.
• Perform field walkdowns and ensure compliance with approved standards.
• Provide engineering support for plant utilities and systems.
• Collaborate to develop maintenance templates and procedures.
• Support maintenance strategies and troubleshooting.

Skills

Communication

cGMP knowledge

FDA/Regulatory knowledge

MS Office

Troubleshooting

Presentation

Education

Bachelor's Degree in Engineering

Job description

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: https://www.fujifilm.com/us/en/about/region/careers

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) or other highly regulated environment

Preferred Skills

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. X No 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 60 minutes
• Ability to sit for prolonged periods of time. No X Yes 60 minutes
• Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
• Ability to operate machinery and/or power tools. No X Yes
• Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 50 lbs.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions. No X Yes

EEO Information

Fujifilm is committed to 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.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).