Biomanufacturing Operations Specialist I

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive pay and benefits

Growth opportunities

Safety-first culture

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Specialist I to support day-to-day operations, documentation, and continuous improvement in a fast-paced biomanufacturing environment. You will coordinate batch readiness, update templates, resolve floor issues, and ensure cGMP compliance, assisting with inventory using SAP and participating in technology transfer and audits.

This role requires a high school diploma with extensive related experience or a degree with direct

Qualifications

• Must have strong cGMP manufacturing operations experience.
• Ability to understand sequence and cadence of manufacturing activities.
• Experience updating and creating manufacturing documents on schedule.

Responsibilities

• Support operational readiness during project phases, including site commissioning and qualification.
• Serve as a process SME for assigned areas; support troubleshooting to restore and sustain reliable operations.
• Coordinate batch planning: create process templates, import, and manage preventive maintenance (PMs).
• Keep documentation current and accurate, including timely redlines and process improvements.
• Coordinate non-batch activities such as changeovers, PMs, and column packing.
• Assist with inventory management; use SAP to support efficient manufacturing operations.
• Support technology transfer activities within manufacturing.
• Ensure safety and cGMP compliance in all manufacturing environments.
• Manage/perform/support quality records including change management, investigations, CAPAs, and CI initiatives.
• Identify and/or lead improvement projects within drug substance manufacturing.
• Assist and support internal/external inspections and audits.
• Perform other duties as assigned.

Skills

cGMP operations

Process knowledge

Document control

SAP experience

Education

High School diploma / GED

Associate's degree

Bachelor's degree

Tools

SAP

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Specialist I to support day-to-day operations, documentation, and continuous improvement in a fast-paced biomanufacturing environment. You will coordinate batch readiness, update templates, resolve floor issues, and ensure cGMP compliance, assisting with inventory using SAP and participating in technology transfer and audits.

This role requires a high school diploma with extensive related experience or a degree with direct