Manufacturing Support Associate 2 (Recipe Driven Operations - Electronic Records)

This role will perform manufacturing support activities to ensure compliant and reliable production. This manufacturing facility is 24/7 operational and the role may require to be flexible with working hours.

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: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You’ll Do

• During the project phase, leads operational readiness initiatives as well as site commissioning and qualification efforts
• Leads troubleshooting for their respective process area
• Recommends and performs documentation updates
• Coordinates non-batch activities and creation of associated documentation for tech transfer, changeover, preventive maintenance plans (PMs), column packing
• Creates change management records, investigations, corrective and preventive actions (CAPAs) and continuous improvement (CI) activities to support manufacturing
• Executes and drives general improvement projects within drug substance manufacturing
• Works with cross-functional groups to organize equipment startup and transfer into GMP manufacturing
• Utilizes documentation to configure electronic batch records for specific products and process areas
• Collaborates cross-functionally to understand process steps, process parameters, and process samples required for electronic batch record
• Supports inspections and audits by providing requested manufacturing documents
• Other duties as assigned
  
  

Basic Requirements

• High School Diploma or GED and 6 years of related experience OR
• Associates degree with 4 years of direct experience OR
• BA/BS with 2 years of direct experience
• Equivalent Military training/experience
  
  

Preferred Requirements

• Associates or Bachelor’s in life sciences or engineering
• Experience with Manufacturing Execution System (MES), preferably with Syncade
• Experience managing records through Electronic Document Management System (EDMS) for compliance and efficiency, preferably with Veeva
• BioWorks or BTEC Capstone cGMP coursework preferred
  
  

Physical Requirements

PHYSICAL DEMANDS

• Ability to discern audible cues
  
  

WORKING ENVIRONMENT

PHYSICAL DEMANDS

• 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.
  
  

ENVIRONMENTAL CONDITIONS

• 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 (FDBN_PNC@fujifilm.com).