Manufacturing Support Associate 1, Documentation

Fujifilm

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not Disclosed

Posted on: 18 days ago

Vacancies: 1 Vacancy

Department:

Manufacturing

Job Summary

Position Overview

Help power a worldclass 24/7 manufacturing operation by ensuring production runs safely compliantly and on schedule. As a Manufacturing Support Associate I with a documentation focus youll be at the heart of operational readiness record accuracy and continuous improvementenabling teams to deliver lifechanging products with confidence.

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:

Lead operational readiness initiatives that prepare teams processes and systems for startup.
Lead site commissioning and qualification efforts to ensure facilities and equipment are ready for compliant use.

In operations:

Support and participate in troubleshooting within assigned process areas to quickly resolve issues and minimize downtime.
Perform documentation updates to maintain accurate compliant records and enable reliable production.
Create nonbatch activities and develop associated documentation for technology transfer changeover preventive maintenance plans (PMs) and column packing.
Support change management records investigations corrective and preventive actions (CAPAs) and continuous improvement (CI) activities that strengthen manufacturing performance.
Support inspections and audits by providing requested manufacturing documents and data.
Perform other duties as assigned to meet production and quality goals.

Minimum qualifications

High School Diploma or GED and 4 years of related experience; or
Associate degree in life sciences and 2 years of direct experience; or
Bachelors degree (BA/BS) in life sciences with no experience; or
Equivalent military training/experience

Skills and abilities:

Strong verbal and written communication skills
Expertise in Microsoft Office especially Word
Strong time management; ability to meet deadlines
Ability to adapt in a fastpaced environment and pivot as priorities change
Critical thinking and superior problemsolving skills
Teambased mindset; ability to build relationships and work effectively in a global team environment
Ability to update and create documents on schedule with high attention to detail

Preferred qualifications

Previous current Good Manufacturing Practice (cGMP) manufacturing operations experience
Understanding of change management investigations corrective and preventive actions (CAPAs) and continuous improvement (CI)
BioWorks or BTEC Capstone cGMP coursework
Pharmaceutical manufacturing experience

Why this role matters

Make a direct impact on reliable compliant manufacturing outcomes
Grow expertise across documentation troubleshooting and operational excellence
Collaborate with crossfunctional teams in a dynamic missiondriven 24/7 environment

Ready to build your manufacturing career on a strong documentation foundation Apply today.

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.

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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:

Position OverviewHelp power a worldclass 24/7 manufacturing operation by ensuring production runs safely compliantly and on schedule. As a Manufacturing Support Associate I with a documentation focus youll be at the heart of operational readiness record accuracy and continuous improvementenabling te...