Manufacturing Specialist 1, Campaign Readiness

About the role

Join a high-growth biomanufacturing site and help ensure safe, compliant, and reliable production. As a Manufacturing Specialist I, you’ll be a hands-on problem solver who supports day-to-day operations, documentation, and continuous improvement—keeping batches on plan and the plant audit-ready. You’ll be the go-to partner for manufacturing operations: coordinating batch readiness, improving templates and documents, resolving issues on the floor, and driving compliance activities that keep our products moving to patients.

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.

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 continuous improvement initiatives.
• Identify and/or lead improvement projects within drug substance manufacturing.
• Assist and support internal/external inspections and audits.
• Perform other duties as assigned.

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.

Minimum Qualifications

• Strong cGMP manufacturing operations experience.
• Understanding of operations sequence and cadence of activities.
• Prior experience updating and creating manufacturing documents on schedule.

Preferred Qualifications

• BioWorks or BTEC Capstone cGMP coursework.
• Experience supporting SAP in manufacturing environments.
• Demonstrated success driving CI, investigations, and CAPAs.

Skills for success

• Strong verbal and written communication.
• Strong time management; able to pivot in a fast-paced, 24/7 setting.
• Critical thinking and superior problem-solving.
• Team-first mindset; able to build relationships and work effectively across global teams.
• Operates as an independent, fully qualified professional who adapts approach and influences diverse stakeholders.

Physical and work requirements

• Ability to stand for prolonged periods; perform repetitive motions with hands/wrists/fingers.
• Climb/descend ladders and work at heights greater than 4 feet.
• Lift/carry up to 10 lbs (occasionally up to ~33 lbs).
• 20/20 corrected vision with color distinction; ability to discern audible cues.
• May work in small production areas and around active equipment; typical indoor manufacturing environment.