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Manufacturing Specialist 1, Drug Product Process

Job Location:

Holly Springs, MS - USA

Monthly Salary: Not provided by the employer

Posted: 26 July 2026 (30+ days ago)

Application Deadline: 23 October 2026

Vacancies: 1 Vacancy

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Job Summary

Position Overview

Help bring life-changing medicines to patients by ensuring reliable compliant manufacturing. As a Manufacturing Specialist I DP youll be a hands-on problem solver and process SME who keeps operations running smoothly in a 24/7 environmentdriving documentation excellence tech transfer readiness and continuous improvement across Drug Product Finished Goods.

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

About Us We are a high-growth 24/7 biopharmaceutical manufacturing site focused on delivering high-quality drug products safely and efficiently. Our team values collaboration learning and operational excellence. Youll join a global cross-functional community where your voice matters and your work makes a direct impact on patients.

Responsibilities

Support operational readiness during the project phase including site commissioning and qualification efforts.
Troubleshoot process issues and act as a process subject matter expert (SME) for assigned area(s).
Coordinate batch planning including process template creation import and the management of Preventative Maintenance (PMs).
Own perform or drive major documentation updates (including initiating new documents for new processes).
Coordinate non-batch activities such as changeover PMs and Aseptic Process Simulation (APS).
Support MSAT with technology transfer activities within manufacturing.
Ensure manufacturing operations adhere to all compliance and safety procedures.
Create and update Electronic Batch Records (EBRs) and Paper Batch Records.
Manage perform initiate or support change management records investigations Corrective and Preventive Actions (CAPAs) and Continuous Improvement (CI) activities.
Manage projects lead execution and participate in projects within Drug Product Finished Goods.
Assist and support inspections and audits to ensure compliance in the manufacturing environment.
Assist the Manager with projects and training as needed.
Collaborate effectively in small cross-functional teams; mentor and guide junior associates.
Flexibility with working hours and shift rotation to support a 24/7 manufacturing facility.

Within this role youll be successful if you bring:

Strong verbal and written communication skills.
Strong time management skills.
Ability to adapt in a fast-paced environment pivot and adjust plans accordingly.
Ability to think critically and demonstrate superior problem-solving skills.
Ability to analyze and troubleshoot simple to moderate system and component-related issues.
Ability to coordinate and facilitate effective small cross-functional teams.
Ability to mentor and guide junior-level associates.
Ability to effectively present information to others.
Team-based attitude and ability to work in a global team environment build relationships and communicate effectively with others.

Minimum Qualifications

High School Diploma or Equivalent with 9 years of applicable industry experience OR
Bachelors degree with 5 years of applicable industry experience OR
Masters degree with 3 years of applicable industry experience OR
PhD without experience OR
Equivalent Military Experience

High degree of understanding of operations sequence and cadence of activities in a manufacturing environment.

Competitive compensation with potential shift differentials for 24/7 operations.
Comprehensive health and wellness benefits.
Retirement savings and financial wellness support.
Paid time off paid holidays and flexible scheduling where business needs allow.
Professional development mentorship and training opportunities.
Inclusive team-oriented culture with global collaboration and opportunities to grow your career.
Recognition programs and opportunities to lead and influence process improvements.

We welcome applicants from all backgrounds and experiences. If youre excited to contribute to safe compliant and efficient manufacturingand to grow your impact in a collaborative environmentwed 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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