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Manufacturing Specialist 1

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 15 August 2026 (29 days ago)

Application Deadline: 29 November 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

Join a 24/7 state-of-the-art biopharmaceutical manufacturing site and play a pivotal role in ensuring every record plan and process is accurate compliant and inspection-ready. As a Manufacturing Specialist I youll keep production moving reliably and safely by owning documentation batch readiness and day-to-day manufacturing support that enables life-changing medicines to reach patients.

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

Were a mission-driven biopharmaceutical manufacturing organization focused on reliable compliant drug substance production. We partner across operations quality engineering and supply chain to deliver for patients and clients with excellence and speed. Our culture is inclusive safety-minded and improvement-drivenwhere diverse perspectives and teamwork fuel better outcomes.

Commitment to CGMP data integrity and operational excellence
Collaborative environment with cross-functional problem solving
Growth mindset with opportunities to learn new platforms and processes
24/7 operations that support flexibility and teamwork across shifts

Responsibilities

You will support end-to-end manufacturing readiness and documentation accuracy from project phase through steady-state operations.

During project phase:

Support operational readiness initiatives and contribute to site commissioning and qualification activities

Serve as a process subject matter expert (SME) for your area(s); support troubleshooting to maintain reliable production
Coordinate batch planning including process template creation and import
Plan and manage non-batch activities such as changeover preventive maintenance (PMs) and column packing
Maintain accurate current production documentation; execute timely updates redlines and process improvements
Assist with inventory management; support efficient operations leveraging SAP
Support technology transfer within the manufacturing domain
Ensure adherence to safety policies and CGMP compliance across the manufacturing environment
Initiate manage perform or support change management records investigations corrective and preventive actions (CAPAs) and continuous improvement (CI) activities
Identify and/or drive improvement projects within drug substance manufacturing
Assist and support internal/external inspections and audits; help ensure the area remains inspection-ready
Perform other duties as assigned
Note: This is a 24/7 facility; flexibility with working hours and shift rotation may be required

Minimum qualifications (must-have):

High School Diploma/GED and 10 years of related experience; OR
Associates degree preferably in life sciences or engineering with 8 years of direct experience; OR
Bachelors degree preferably in life sciences or engineering with 6 years of direct experience; OR
Equivalent military experience/training
Strong CGMP manufacturing operations experience
Understanding of operations sequence and cadence of activities
Prior experience updating and creating manufacturing documents per schedule

Preferred qualifications:

BioWorks or BTEC Capstone CGMP coursework
Experience collaborating across global teams and with cross-functional partners

Core skills for success:

Strong verbal and written communication; able to adapt style for different audiences
Strong time management; able to prioritize in a fast-paced dynamic setting
Critical thinking with strong problem-solving skills
Team-first mindset; ability to build relationships and work effectively in a global team environment
Comfortable working independently with general guidance and taking ownership of outcomes

Reporting structure:

This is an individual contributor role with no direct or indirect reports

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

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About Company

Fujifilm

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