Manufacturing Specialist 1, Materials

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 95,000 - 125,000; Full time

Job summary

FUJIFILM Biotechnologies is seeking a Manufacturing Specialist I, Materials for a 24/7 biomanufacturing site in Holly Springs, NC. You will support operational readiness, document control, and issue resolution to sustain production quality and schedule adherence.

Role involves coordinating batch planning, maintenance management, and changeovers while ensuring compliance with cGMP and safety requirements. Shift rotation flexibility is required.

Qualifications

• High School Diploma or GED with 10 years related experience or higher degrees with relevant experience.
• Experience updating and creating manufacturing documents according to schedule.
• Strong cGMP manufacturing operations experience preferred.

Responsibilities

• Support operational readiness initiatives including site commissioning and qualification efforts.
• Troubleshoot as process subject matter expert in assigned area(s).
• Coordinate batch planning, template creation, imports, and preventive maintenance management.
• Maintain current documentation; update records and drive redlines and process improvements.
• Coordinate non-batch activities including changeovers, preventive maintenance, and column packing.
• Assist with inventory management and use of SAP for manufacturing operations.
• Support technology transfer within manufacturing domain.
• Ensure compliance with procedures and safety requirements.
• Manage or support change management records, investigations, CAPAs, and continuous improvement.
• Identify and drive improvement projects in drug substance manufacturing.
• Assist and support inspections and audits to maintain compliance.

Skills

Verbal communication

Written communication

Time management

Adaptability

Critical thinking

Team collaboration

Education

High School Diploma/GED + 10 years experience

Associate's degree in life sciences or engineering + 8 years direct experience

Bachelor's degree in life sciences or engineering + 6 years direct experience

Equivalent military experience/training

Tools

SAP

Job description

Help build and sustain reliable, compliant manufacturing at a world ‑ class, 24/7 biomanufacturing site. As a Manufacturing Specialist I, Materials, you will be a key driver of operational readiness, daily production excellence, and continuous improvement. This role supports a round ‑ the ‑ clock operation and may require flexibility with working hours and shift rotation.

Job Description

Why this role matters

You will blend hands ‑ on support with strong documentation, planning, and problem ‑ solving to keep production running smoothly and safely. Your work will directly impact product quality, schedule adherence, and the success of technology transfers and inspections.

What you’ll do

During Project Phase

• Support operational readiness initiatives as well as site commissioning and qualification efforts.

In Operations

• Support troubleshooting, acting as a process subject matter expert for assigned area(s).
• Coordinate batch planning, including process template creation, import, and management of preventive maintenance activities.
• Maintain accurate, current documentation; drive timely updates to records and implement redlines and process improvements.
• Coordinate non‑batch activities, including changeovers, preventive maintenance, and column packing.
• Assist with inventory management and support use of enterprise systems (e.g., SAP) for effective manufacturing operations.
• Support technology transfer within the manufacturing domain.
• Ensure compliance with procedures and safety requirements in the manufacturing environment.
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions, and continuous improvement activities.
• Identify and drive improvement projects in drug substance manufacturing.
• Assist and support internal and external inspections and audits to maintain compliance.
• Perform other duties as assigned to meet production and quality objectives.

Work schedule

• 24/7 operational facility; flexibility with working hours and shift rotation is required.

Minimum Education And Experience

• High School Diploma/GED and 10 years of related experience; OR
• Associate's degree, preferably in life sciences or engineering, with 8 years of direct experience; OR
• Bachelor's degree, preferably in life sciences or engineering, with 6 years of direct experience; OR
• Equivalent military experience/training.

Preferred Qualifications

• Strong current Good Manufacturing Practice (cGMP) manufacturing operations experience.
• Solid understanding of operations sequence and cadence of activities.
• Prior experience updating and creating manufacturing documents according to schedule.

Training and certifications

• Preferred: BioWorks or BTEC Capstone cGMP coursework.

What helps you succeed here

• Strong verbal and written communication skills.
• Excellent time management and the ability to prioritize in a fast ‑ paced environment.
• Adaptability—able to pivot and adjust plans as priorities shift.
• Critical thinking and superior problem ‑ solving skills.
• A team ‑ first mindset with the ability to work effectively in a global, cross ‑ functional environment and build strong relationships.

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]).