Digital Operations Associate - MES & Data for Biotech

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

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.