Manufacturing Specialist 1, Drug Product Process

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Shift differentials

Health benefits

Retirement savings

PTO & holidays

Professional development

Inclusive culture

Recognition programs

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks a Manufacturing Specialist I, DP to ensure reliable, compliant manufacturing in a 24/7 environment. You’ll drive documentation excellence, tech transfer readiness, and continuous improvement across Drug Product Finished Goods.

You’ll be a hands-on SME, coordinating batch planning, updating records, and mentoring junior staff while maintaining tight adherence to safety and quality standards.

Qualifications

• High School Diploma or Equivalent with 9 years of applicable industry experience.
• Bachelor’s degree with 5 years of applicable industry experience.
• Master’s degree with 3 years of applicable industry experience.
• PhD without experience.
• Equivalent Military Experience.

Responsibilities

• Support project readiness during commissioning and qualification efforts.
• Troubleshoot process issues as SME for assigned areas.
• Coordinate batch planning and manage Preventative Maintenance activities.
• Own or drive major documentation updates for new processes.
• Coordinate non-batch activities such as changeover, PMs, and APS.
• Support technology transfer activities within manufacturing (MSAT).
• Ensure manufacturing operations adhere to compliance and safety procedures.
• Create and update Electronic/ Paper Batch Records.
• Manage CAPAs and CI activities and support inspections/audits.
• Lead/participate in projects within Drug Product Finished Goods.
• Mentor junior associates and collaborate in cross-functional teams.

Skills

Strong communication

Problem-solving

Team collaboration

Adaptability

Time management

Education

High School Diploma or Equivalent with 9 years of industry experience

Bachelor’s degree with 5 years of industry experience

Master’s degree with 3 years of industry experience

PhD without experience

Equivalent Military Experience

Tools

Electronic Batch Records (EBR)

Job description

Help bring life-changing medicines to patients by ensuring reliable, compliant manufacturing. As a Manufacturing Specialist I, DP, you’ll be a hands-on problem solver and process SME who keeps operations running smoothly in a 24/7 environment-driving 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, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof. We’re 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 we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together! Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity. Fujifilm is globally headquartered in Tokyo with over 70,000 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: https://www.fujifilm.com/us/en/about/region/careers

Job 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. You’ll 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, you’ll 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
• Bachelor’s degree with 5 years of applicable industry experience OR
• Master’s degree with 3 years of applicable industry experience OR
• PhD without experience OR
• Equivalent Military Experience

Preferred

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

Benefits

• 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 you’re excited to contribute to safe, compliant, and efficient manufacturing—and to grow your impact in a collaborative environment,we’d love to hear from you.

EEO Information

Fujifilm is committed to 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 ([e-mail]).