Manufacturing Support Associate 3 - Tech Transfer

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 50,000 - 65,000; Full time

Job summary

A leading biopharmaceutical company in North Carolina seeks a Manufacturing Support Associate to collaborate on tech transfer and support reliable production. Responsibilities include leading operational readiness initiatives, troubleshooting processes, and coordinating training. Candidates should have a high school diploma with 8 years of related experience, or an Associate's degree with 6 years of experience. Join us in shaping the future of medicine with a dynamic culture and growth opportunities.

Qualifications

• Understanding of operational readiness and commissioning.
• Ability to coordinate batch planning and preventive maintenance.
• Skills in troubleshooting manufacturing processes.

Responsibilities

• Lead operational readiness initiatives during projects.
• Support reliable production and troubleshoot issues.
• Coordinate training and documentation updates.

Skills

Operational readiness

Troubleshooting

Training development

Change management

Education

High school diploma with 8 years experience

Associate's Degree with 6 years experience

BS/BA with 4 years experience

Job description

The Manufacturing Support Associate 3 – Tech Transfer will collaborate with MSAT and Manufacturing to ensure product and campaign needs are met. This manufacturing facility is 24/7 operational and the role may require you to be flexible with working hours.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By the 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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• Lead operational readiness initiatives during the project phase as well as site commissioning and qualification efforts.
• Support reliable production through activities during regular operations.
• Lead troubleshooting, including acting as a process subject‑matter expert (SME) for relevant process areas.
• Coordinate batch planning, including process template creation and import and management of preventive maintenance plans (PMs).
• Recommend and perform documentation updates.
• Initiate and/or support training, onboarding, and curriculum development and management.
• Coordinate non‑batch activities and create associated documentation for changeover, PMs, column packing.
• Support tech transfer.
• Initiate or support change‑management records, investigations, corrective and preventive actions (CAPAs), and continuous improvement (CI) activities.
• Identify and/or drive highly technical improvement projects in DSM.
• Support inspections and audits.
• Perform other duties as assigned.

Basic Requirements

• High school diploma with 8 years of related experience.
• Associate’s Degree with 6 years of direct experience.
• BS/BA with 4 years of direct experience.
• Equivalent military experience or training.

Preferred Requirements

• Associate or Bachelor’s Degree preferably in life sciences or engineering.
• BioWorks or BTEC Capstone cGMP coursework preferred.

Physical Requirements

• Ability to discern audible cues.
• 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 wrist, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 10 lbs.
• 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 ([e-mail]).