Digital Operations Associate, Downstream
Full-time
FUJIFILM Biotechnologies
Position Overview 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: Job Description About Us 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; escalate 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.
- 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
- 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
- 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
- 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
Vacancy posted 15 days ago
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