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 youll be a hands-on problem solver who supports day-to-day operations documentation and continuous improvementkeeping batches on plan and the plant audit-ready.

Youll 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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

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

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

What youll 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
• Associates degree preferably in life sciences or engineering with 8 years of direct experience; OR
• Bachelors 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 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 committedto 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 ().

Required Experience:

IC