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Manufacturing Specialist 1, Tech Transfer

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 28 October 2026 (17 hours ago)

Application Deadline: 25 January 2027

Vacancies: 1 Vacancy

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Job Summary

Position Overview

Join a 24/7 state-of-the-art biomanufacturing operation where your expertise keeps life-changing therapies moving safely and reliably. As a Manufacturing Specialist 1 youll be a process-focused problem-solver who drives operational readiness cGMP compliance and continuous improvementhelping teams deliver high-quality drug substance every shift of the day.

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

We are a growth-minded biomanufacturing organization with a commitment to compliant reliable production and a culture of safety collaboration and continuous improvement. Our facility operates around the clock to support partners and patients worldwide. Here youll leverage your manufacturing know-how to influence outcomes across the floorpartnering with operations quality engineering and technical teams to enable on-time right-first-time batches.

24/7 manufacturing environment with rotating shifts and flexibility
Team-centric inclusive culture that values diverse experiences and perspectives
Strong focus on cGMP standards operational excellence and proactive problem-solving

Responsibilities

During project phase:

Support operational readiness initiatives including site commissioning and qualification efforts

Serve as a process subject matter expert (SME) for assigned area(s); support troubleshooting and issue resolution
Coordinate batch planning including process template creation and import and manage preventative maintenance (PMs)
Maintain current and accurate documentation; complete timely updates to records (redlines and process improvements)
Coordinate non-batch activities including changeovers PMs and column packing
Assist with inventory management and support effective manufacturing operations using SAP
Support technology transfer activities within the manufacturing domain
Ensure adherence to safety and compliance procedures within the manufacturing environment
Initiate perform manage 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 with and support internal/external inspections and audits to maintain a compliant state of operations
Perform other duties as assigned

Minimum education and experience requirements (must meet one):

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

Preferred education experience and training:

Strong cGMP manufacturing operations experience
Understanding of operations sequence and cadence of activities
Prior experience updating and creating manufacturing documents per schedule
BioWorks or BTEC Capstone cGMP coursework preferred

Key skills and attributes:

Strong verbal and written communication skills
Strong time management and the ability to adapt in a fast-paced environment
Critical thinking with superior problem-solving skills; able to pivot and adjust plans
Team-focused mindset; ability to build relationships and collaborate effectively including in a global team environment
Comfortable working independently with sound judgment and escalation when appropriate

This facility operates 24/7; flexibility with working hours and shift rotation may be required

Competitive compensation with shift differentials (where applicable)
Comprehensive health benefits (medical dental vision)
Retirement savings plan with company contribution
Paid time off paid holidays and leave programs
Company-paid life and disability coverage
Education assistance and professional development including cGMP training
Opportunities to contribute to CI initiatives tech transfer and cross-functional projects
Inclusive culture focused on safety teamwork and career growth

If youre passionate about enabling compliant reliable manufacturing and enjoy the challenge of supporting a dynamic round-the-clock operation wed love to hear from you. Apply today.

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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