Manufacturing Specialist 1

Position Overview

The Manufacturing Specialist 1 performs manufacturing support activities to ensure compliant and reliable production. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

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

• Supports trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s)
• Coordinates Batch Planning including process template creation, import and management of preventative maintenance (PMs)
• Maintains current and accurate documentation, ensuring timely updates of records (redlines and process improvements)
• Coordinates of non-batch activities including Changeover, PMs and column packing
• Assists in inventory management and offers support in utilizing SAP for effective manufacturing operations
• Supports tech transfer within manufacturing domain
• Ensures compliance and safety procedures are followed in manufacturing environment
• Manages, performs, initiates, or supports change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
• Identifies and/or drives improvement projects in drug substance manufacturing
• Assists and supports inspections and audits. Provides support to ensuring compliance within the manufacturing environment
• Other duties as assigned

Basic 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 verbal and written communication skills
• Strong time management skills
• Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly
• Ability to think critically and have superior problem-solving skills.
• Team based attitude and ability to work in a global team environment, build relationships, and communicate effectively with others

Preferred Requirements

• Strong cGMP manufacturing operations experience
• Understanding of operations sequence and cadence of activities
• Prior experience in updating and creating manufacturing documents per schedule
• BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Ability to discern audible cues
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time
• Ability to sit for prolonged periods of time
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
• Ability to conduct work that includes moving objects up to 10 pounds
• Will work in heights greater than 4 feet

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]).