Manufacturing Specialist 1, Campaign Readiness

Fujifilm • Holly Springs, NC

1d • Onsite

About The Position

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.

Requirements

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

Nice To Haves

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

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.

Benefits

• Competitive pay and benefits (healthcare, retirement, paid time off).
• Learning and growth opportunities within a cutting-edge biomanufacturing organization.
• Inclusive, safety-first culture with continuous improvement at its core.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED