Manufacturing Support Associate 1 or 2 (Experience Based)

Position Overview

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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 : Description

What Youll 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

Manufacturing Support Associate 1

• High School Diploma / GED and 4 years related experience OR
• Associate degree in life sciences with 2 years of direct experience OR
• BA / BS in life sciences with no experience OR
• Equivalent Military training / experience

Manufacturing Support Associate 2

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

WORKING ENVIRONMENT

PHYSICAL DEMANDS

ENVIRONMENTAL CONDITIONS

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 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 committedto 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 ().

Required Experience :

IC

Key Skills

Lean Manufacturing,Six Sigma,Continuous Improvement,ISO 9001,Lean Six Sigma,Management Experience,Manufacturing & Controls,5S,Manufacturing Management,Kaizen,Chemistry,Manufacturing

Employment Type : Unclear

Department / Functional Area : Manufacturing

Experience : years

Vacancy : 1