Manufacturing Support Associate 2, Drug Product

Position Overview

The Manufacturing Support Associate 2 provides reliable support to the Drug Product Manufacturing operation during the establishment of the facility and processes. This position supports the creation of standard operating procedures, processes, trainings and documentation along with supporting tech transfer, batch planning, documentation updates and coordination of non-batch activities including changeover, PMs, deviation management and audit preparation.

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

• During the project phase, support operational readiness initiatives as well as site commissioning and qualification
• Owns and drives drug product operational readiness document plan, contribute to preparation of standard operating processes (SOPs) and documentation packages as defined by the project plan
• Participates in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required
• Actively participates in establishment of batch handling processes for Drug product manufacturing
• Executes and drives minor projects and initiate change management request including optimization projects
• Leads and guides shop floor deviation investigation from initiation through closure
• Provides training and mentor junior level team members
• Perform other duties as assigned

Basic Requirements

• High School Diploma or GED with 6 years direct experience OR
• Associate's degree with 4 years of direct experience OR
• Bachelor's degree with 2 years of direct experience OR
• Equivalent Military training or experience

Preferred Requirements

• Associate degree in life sciences
• BA/BS, in life sciences or engineering\Prior cGMP experience from a pharmaceutical production environment
• Preferable operational experience with formulation, filling and visual inspection processes and production equipment
• BioWorks or BTEC Capstone cGMP coursework preferred

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• 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 writs, hands and/or fingers.
• Ability to operate machinery and/or power tools.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions

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]).