Manufacturing Associate 4, Downstream

FUJIFILM; Holly Springs (NC); Sur place; USD 30 000 - 36 000; Plein temps

Résumé du poste

FUJIFILM Biotechnologies in Holly Springs, NC, is hiring a Manufacturing Associate 4 to execute and document manufacturing activities in a 24/7 cGMP environment. The role supports readiness, process transfer, and validation, with flexible shift rotations to maintain safe, compliant production.

The position requires strong troubleshooting, documentation, and the ability to train other associates, with a focus on safety, quality, and operational excellence.

Qualifications

• Strong troubleshooting and technical documentation skills.
• Ability to train, guide, and provide technical support to other associates.
• Advanced understanding of manufacturing cadence and shift activities.
• Advanced knowledge of production equipment and assigned unit operations.
• Strong time-management skills and the ability to adjust to changing priorities.

Responsabilités

• Lead and execute complex manufacturing processing and support activities within an assigned functional area.
• Ensure manufacturing activities are completed and documented according to SOPs and cGMP requirements.
• Support operational readiness, process transfer, procedure creation, equipment testing, commissioning, and validation.
• Perform process monitoring and in-process testing.
• Assist with cycle counts and materials management.
• Guide and train less-experienced manufacturing associates.
• Lead or support troubleshooting of manufacturing and operational issues.
• Support senior associates and supervisors with coordinating daily floor activities.
• Provide advanced equipment and process knowledge within qualified unit operations.
• Identify potential safety, quality, documentation, or operational concerns and escalates them appropriately.
• Perform other duties as assigned.

Connaissances

Troubleshooting

Technical documentation

Time management

Formation

High school diploma or GED

Associate degree

Bachelor’s degree

Equivalent military training

Description du poste

Position Overview

Help deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 4 to assist with the execution and documentation of manufacturing processing activities in a cGMP environment. The role supports project-phase readiness and steady-state operations in a 24/7 facility—helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required.

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

What You’ll Do

• Lead and execute complex manufacturing processing and support activities within an assigned functional area.
• Ensure manufacturing activities are completed and documented according to SOPs and cGMP requirements.
• Support operational readiness, process transfer, procedure creation, equipment testing, commissioning, and validation.
• Perform process monitoring and in-process testing.
• Assist with cycle counts and materials management.
• Guide and train less-experienced manufacturing associates.
• Lead or support troubleshooting of manufacturing and operational issues.
• Support senior associates and supervisors with coordinating daily floor activities.
• Provide advanced equipment and process knowledge within qualified unit operations.
• Identify potential safety, quality, documentation, or operational concerns and escalates them appropriately.
• Perform other duties as assigned.

Minimum Qualifications

• High school diploma or GED with 6 years of life sciences manufacturing experience;OR
• Associate degree with 4 years of life sciences manufacturing experience; OR
• Bachelor’s degree with 2 years of life sciences manufacturing experience; OR
• Equivalent military training or experience.

Additional Qualifications

• Strong troubleshooting and technical documentation skills.
• Ability to train, guide, and provide technical support to other associates.
• Advanced understanding of manufacturing cadence and shift activities.
• Advanced knowledge of production equipment and assigned unit operations.
• Strong time-management skills and the ability to adjust to changing priorities.

Physical Demands and Working Environment:

• Will work in heights greater than 4 feet.
• Will work in environment which may necessitate respiratory protection.
• Ability to discern verbal cues.
• Ability to sit for prolonged periods of time.
• Ability to stand for prolonged periods of time.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to conduct repetitive tasks that utilize wrists, hands and/or fingers.
• Ability to bend, push/pull, reach to retrieve materials from 18” - 60” in height, and use twisting motions.
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.

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 ([e-mail]).