Digital Operations Associate

FUJIFILM Holdings America Corporation; Holly Springs (NC); Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

Hybrid work flexibility

Health insurance

401(k) plan

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, invites applicants to join a Digital Operations team supporting cGMP drug substance production with MES, data historians, and electronic logbooks.

The role emphasizes learning and collaboration in a high-impact environment, with opportunities to grow skills in digital manufacturing and regulatory compliance. Hybrid work options may be available depending on site needs.

Qualifications

• Foundational knowledge of MES and electronic batch documentation.
• Ability to learn digital manufacturing systems quickly.
• Knowledge of cGMP principles and data integrity requirements.

Responsibilities

• Assist deployment and sustainment of digital manufacturing tools (MES, data historians, electronic logbooks).
• Configure recipe-driven operations and prepare documentation for review and approval.
• Collect data, perform routine analysis, and monitor systems for reliability.
• Follow cGMP, data integrity, and compliance standards; escalate issues to senior staff.
• Assist with user training and develop standard work materials.
• Support cross-functional digital integration and electronic batch execution.

Skills

MES knowledge

Electronic batch docs

Data integrity

Attention to detail

Communication

Cross-functional collaboration

Problem solving

Manufacturing familiarity

Education

Bachelor’s degree in Life Sciences or Engineering

Associate’s degree in Life Sciences or Engineering

Equivalent practical experience

Tools

PI/Data Historian

LIMS

ERP integration

Job description

Position Overview

Make a meaningful impact at the intersection of biomanufacturing and digital operations. If you’re excited to learn and grow while supporting cGMP production with modern tools like MES, data historians, and electronic logbooks, this role is a great entry point into a high-impact, highly collaborative environment.

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

About Us

• We are a cGMP biomanufacturing organization focused on reliable, compliant, and efficient drug substance production.
• Our Digital Operations team partners closely with Manufacturing, Automation, and Quality to deploy and sustain recipe-driven operations and electronic batch execution.
• We value learning, collaboration, and continuous improvement—and we set our teams up for success with clear procedures, supportive leadership, and opportunities to build new skills.

Responsibilities

• Support deployment and sustainment of digital manufacturing tools (e.g., MES, data historians, electronic logbooks) by executing clearly defined tasks within established procedures.
• Assist with configuration activities for recipe-driven operations and prepare documentation for review and approval.
• Perform basic data collection, routine analysis, and system monitoring to help ensure consistent, reliable digital operations.
• Follow cGMP, data integrity, and compliance standards; elevate non-routine issues to senior team members.
• Contribute to user training by preparing materials, documenting standard work, and conducting walkthroughs under supervision.
• Participate in cross-functional coordination to support digital integration and electronic batch execution.
• Identify straightforward opportunities to streamline tasks or standard work and contribute to continuous improvement.
• Provide on-call support participation as scheduled, with guidance from senior staff.
• Maintain accurate records, logs, and status updates for assigned tasks.
• Perform other duties as assigned.

What you’ll bring (Minimum Qualifications)

• One of the following:
  • High School Diploma/GED with 4 years of related experience; or
  • Associate’s degree in Life Sciences or Engineering with 2 years of related experience; OR
  • Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field; OR
  • Equivalent practical experience with no prior experience
• Foundational knowledge of MES and electronic batch documentation, with the ability to learn digital manufacturing systems quickly.
• Understanding of cGMP principles and data integrity requirements; applies established procedures and standards.
• Strong attention to detail, organization, and time management; delivers accurate, timely work.
• Clear written and verbal communication; collaborates effectively and seeks feedback.
• Basic problem-solving skills and ability to apply standard techniques to routine issues, escalating when appropriate.
• Familiarity with manufacturing processes and cross-functional collaboration.
• Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call.

Preferred Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or related discipline.
• Experience (internship/co-op/project) supporting digital manufacturing systems (e.g., MES, PI/data historian, DCS/PLC, LIMS, ERP integration).
• Familiarity with GMP/GLP requirements and biological manufacturing environments.

Benefits

• Competitive compensation with opportunities for growth and skill development.
• Comprehensive health and wellness coverage for you and your family.
• Retirement savings plan with company support.
• Paid time off, holidays, and leave programs.
• Training, mentorship, and learning opportunities to accelerate your development in digital manufacturing.
• Potential hybrid work flexibility depending on role and site needs.
• Inclusive, collaborative culture that values diverse perspectives and ensures equitable opportunities.
• Meaningful work that supports compliant, reliable drug substance manufacturing.

Accessibility and Work Environment

• This role supports a 24/7 manufacturing environment and includes rotational on-call participation.
• Work may include time in mechanical/production areas with standard safety requirements and use of powered industrial trucks.
• Ability to sit for up to 60 minutes at a time, stand for up to 30 minutes at a time, operate machinery, and occasionally move objects up to 33 lbs; ability to discern audible cues and work with corrected vision as needed.
• We are committed to providing reasonable accommodations throughout the application and employment process. If you need assistance, please let us know.

If you’re eager to grow your career in digital manufacturing and contribute to reliable, compliant operations, we’d love to hear from you.

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation benefits, 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]).