Manufacturing Specialist 2, DP

This role as Manufacturing Specialist 2 will 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.

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:

What You'll Do

• During the project phase, support operational readiness initiatives as well as site commissioning and qualification efforts.
• Support trouble shooting including acting as a process subject matter expert (SME) for their process respective area(s).
• Coordinate Batch Planning including process template creation and import and management of PMs.
• Own, perform, or drive documentation major documentation updates (Initiate new documents for new processes)
• Coordination of non-batch activities including but not limited to Changeover, PMs, column packing, APS.
• Support tech transfer within manufacturing domain.
• Ensure compliance and safety procedures are followed in manufacturing environment.
• Manage, perform, initiate, or support change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities.
• Lead large scale improvement projects in DPFG
• Assist and support inspections and audits, providing support to ensure compliance within the manufacturing environment.
• Assist in creating work schedules for junior staff.
• Perform other duties as assigned.

Basic Requirements

• High school Diploma or GED with 12 years of related experience

Preferred Requirements

• Associate degree and 10 years of direct experience OR
• BA/BS and 8 years of direct exp OR
• Equivalent Military experience
• Strong manufacturing operations experience
• High degree of understanding of operations sequence and cadence of activities

• Bio Works or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• Will work in environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program
• Will work in environment operating a motor vehicle or Powered Industrial Truck
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• 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 operate machinery and/or power tools
• Ability to conduct work that includes moving objects up to 33 pounds
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions
• Will work in warm/cold environments

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.

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.

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 ).