Digital Operations Associate, Downstream

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive pay

Comprehensive health benefits

Retirement savings plan

Paid time off and holidays

On-call compensation

Education assistance and professional

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Digital Operations Associate to support recipe-driven production, electronic batch execution, and data integrity in a cGMP setting. You will collaborate with Manufacturing, Automation, and Quality to keep life-changing therapies moving.

The role emphasizes deploying digital tools, documentation, and cross-functional coordination, with on-call responsibilities as needed. A foundational understanding of cGMP and data integrity is expected.

Qualifications

• 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.
• Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call
• Foundational understanding of cGMP and data integrity principles
• Strong attention to detail, organization, and time management; clear written and verbal communication
• Basic problem-solving skills and the ability to follow standard procedures, escalating when appropriate

Responsibilities

• Execute tasks to deploy and sustain digital manufacturing tools within established procedures.
• Assist with configuration activities for recipe-driven operations; prepare documentation for review and approval.
• Perform basic data collection, routine analysis, and system monitoring to support digital operations.
• Follow cGMP and data integrity standards; escalate non-routine issues to senior team members.
• Support user training by preparing materials, documenting standard work, and conducting walkthroughs.
• Participate in cross-functional coordination to enable digital integration and electronic batch execution.
• Contribute to continuous improvement by identifying opportunities to streamline tasks or standard work.
• Provide on-call support as scheduled, with guidance from senior staff.
• Maintain accurate records, logs, and status updates for assigned tasks.
• Other duties, as assigned.

Skills

Attention to detail

Written and verbal communication

Problem-solving

24/7 on-call willingness

Education

High school diploma/GED + 4 years related experience

Associate’s degree in Life Sciences or Engineering

Bachelor’s degree in Life Sciences, Engineering, Information Systems, or related field

Equivalent practical experience

Tools

MES

PI/Data Historian

DCS/PLC

LIMS

ERP integration

Job description

Help power safe, efficient, and fully digital manufacturing. As a Digital Operations Associate, you’ll support the tools that enable recipe-driven production, electronic batch execution, and data integrity in a current Good Manufacturing Practices (cGMP) environment. You’ll collaborate across Manufacturing, Automation, and Quality to keep life-changing therapies moving.

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

About Us

Job Description

We are a modern biologics manufacturing organization committed to operational excellence, regulatory compliance, and continuous improvement. Our team leverages digital systems—such as Manufacturing Execution Systems (MES), data historians, and electronic logbooks—to ensure every batch is executed accurately and efficiently. If you’re motivated by purpose, precision, and teamwork, you’ll feel at home here.

Responsibilities

• Execute assigned tasks to deploy and sustain digital manufacturing tools (e.g., MES, data historians, electronic logbooks) within established procedures.
• Assist with configuration activities for recipe-driven operations; prepare documentation for review and approval.
• Perform basic data collection, routine analysis, and system monitoring to support reliable digital operations.
• Follow cGMP and data integrity standards; escal... non-routine issues to senior team members promptly.
• Support user training by preparing materials, documenting standard work, and conducting guided walkthroughs.
• Participate in cross-functional coordination to enable digital integration and electronic batch execution.
• Contribute to continuous improvement by identifying straightforward opportunities to streamline tasks or standard work.
• Provide on-call support participation as scheduled, with guidance from senior staff.
• Maintain accurate records, logs, and status updates for assigned tasks.
• Other duties, as assigned.

Minimum Qualifications (must-have)

• 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; no prior industry experience required
• Willingness to support a 24/7 manufacturing environment as needed, including rotational on-call
• Foundational understanding of cGMP and data integrity principles
• Strong attention to detail, organization, and time management; clear written and verbal communication
• Basic problem-solving skills and the ability to follow standard procedures, escalating when appropriate

Preferred Qualifications (nice-to-have)

• Bachelor’s degree in Life Sciences, Engineering, or related discipline
• Experience (internship, co-op, or project) supporting digital manufacturing systems such as MES, PI/data historian, DCS/PLC, LIMS, or ERP integration
• Familiarity with GMP/GLP requirements and biological manufacturing environments
• Foundational knowledge of MES and electronic batch documentation; ability to learn digital systems quickly
• Experience collaborating cross-functionally with Manufacturing, Quality, and Automation

Work Environment and Physical Requirements

• Works in manufacturing/production spaces; may operate equipment and motor vehicles/Powered Industrial Trucks
• Ability to hear audible cues and work with 20/20 corrected vision, including color distinction
• Able to stand for up to 30 minutes and sit for up to 60 minutes at a time; lift up to 10 lbs routinely and up to 33 lbs occasionally
• May require enrollment in applicable safety programs and adherence to all site safety procedures

Benefits

• Competitive pay with opportunities for growth and skill development
• Comprehensive health and wellness benefits (medical, dental, vision) and employee support resources
• Retirement savings plan with company contribution
• Paid time off and company holidays
• On-call compensation where applicable
• Education assistance, professional development, and training on digital manufacturing systems
• Inclusive, team-centered culture focused on safety, quality, and continuous improvement

We’re an Equal Opportunity Employer. We value and welcome candidates of all backgrounds and experiences. If you don’t meet every preferred qualification, we encourage you to apply—your skills and potential may be a great fit.

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]).