Manufacturing Associate 3, Formulation (2nd Shift 3pm to 11:30pm)

Fujifilm • Holly Springs, NC

16h • Onsite

About The Position

FUJIFILM Biotechnologies is hiring a Manufacturing Associate 3 for its Drug Product manufacturing team in Holly Springs, North Carolina. The role supports a 24/7 operation and involves hands-on component and parts preparation, thawing and formulation, sterile filling, and visual inspection. The associate will help execute and document manufacturing processes, support cGMP compliance and operational excellence, contribute to process improvements, train colleagues, and assist with equipment qualification and facility startup activities. The position may involve shift work, including weekends and potential nights.

Requirements

• High school diploma or GED and at least 4 years of direct experience in a cGMP manufacturing environment; or an associate degree and at least 2 years of direct cGMP manufacturing experience; or a bachelor's degree, preferably in Life Sciences or Engineering; or equivalent military training or experience.
• Ability to assist in troubleshooting and apply sound judgment to assignments.
• Strong verbal and written communication skills.
• Knowledge of production equipment operations within assigned unit operation(s).
• Basic understanding of manufacturing run cadence and the order of shift activities.
• Knowledge of cGMP, safety, and operational procedures.
• Ability to work effectively in a team environment.
• Flexibility for shift rotation and weekend/night work in a 24/7 facility.
• Ability to perform role-specific physical tasks, including lifting or moving up to 33 lbs, repetitive hand and wrist motions, reaching, bending, pushing/pulling, climbing ladders, working at heights greater than 4 feet, and prolonged standing or sitting as required.
• Ability to discern audible cues and perform tasks requiring 20/20 corrected vision, including color vision; respiratory and hearing protection may be required.
• Ability to operate machinery and power tools and, as required, motor vehicles or Powered Industrial Trucks.

Nice To Haves

• Qualified experience with unit operations such as parts washer, autoclave operation, compounding/formulation, filling with isolator technology, or manual/automated visual inspection.
• BioWorks or BTEC Capstone cGMP coursework.

Responsibilities

• Lead, execute, and document manufacturing processing steps and support activities, including process monitoring and control.
• Perform in-process testing such as pH, conductivity, and visual inspection accurately.
• Execute validation protocols in accordance with cGMP Standard Operating Procedures.
• Maintain training qualifications for required manufacturing activities.
• Perform operations across Drug Product unit operations, including parts washer and autoclave, compounding/formulation, sterile filling with isolator technology, and manual and/or automated visual inspection.
• Assist with or lead cycle counts and manage materials for assigned manufacturing areas.
• Assist the lead with daily manufacturing tasks and coordinate daily shift activities as needed.
• Support projects to improve Drug Product manufacturing processes, including training new colleagues.
• Maintain cGMP document compliance and assist with equipment qualification and DPFG facility startup activities.
• Follow safe work practices and promptly escalate issues to maintain product quality and compliance.
• Perform other duties as assigned.

Benefits

• Competitive pay with shift differentials where applicable.
• Comprehensive medical, dental, and vision coverage.
• Paid time off, holidays, and sick leave.
• Retirement savings plan with company contribution.
• Training and development opportunities, including cGMP upskilling and mentorship.
• Inclusive, team-centered culture focused on safety, quality, and continuous improvement.
• Employee assistance and well-being resources.
• Opportunities to contribute to startup and optimization initiatives in a modern Drug Product facility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED