Manufacturing Specialist 1, Campaign Readiness

Position Overview

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. Ready to shape the future of medicine? Let's transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh's thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of "giving our world more smiles." Visit:

Job Description

What you'll do

• 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 (must meet one)

• 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 (must-have skills)

• 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.

What we offer

• 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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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 ([email protected]).