Manufacturing Associate 2, Upstream/Downstream

Fujifilm • Holly Springs, NC

15h • Onsite

About The Position

FUJIFILM Biotechnologies is hiring a Manufacturing Associate 2 to support biopharmaceutical manufacturing in a cGMP environment at its facility in Holly Springs, North Carolina. The position assists with operational readiness and steady-state manufacturing operations in a 24/7 facility, helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required.

The associate supports readiness activities, including procedure review, document preparation, testing, commissioning, and equipment readiness. The role also executes and documents assigned manufacturing processing and support activities according to SOPs and cGMP requirements, performs process monitoring and in-process tests such as pH and conductivity measurements and visual inspections, maintains required training and qualifications, and works with experienced associates, technical staff, and supervisors.

The role requires following technical instructions and safety, quality, and operational procedures, and accurately documenting work. The physical environment may include working at heights, using respiratory or hearing protection, and performing prolonged sitting or standing, ladder climbing, lifting and moving objects up to 33 pounds, repetitive hand and wrist tasks, bending, pushing, pulling, reaching, and twisting.

Requirements

• High school diploma or GED and at least 2 years of related experience, or an equivalent combination of education and experience.
• At least 2 years of direct experience in a cGMP manufacturing environment.
• Knowledge of support process equipment and understanding of cGMPs, safety, and operational procedures.
• Ability to perform operations and document them accurately, and to follow technical instructions.
• Strong verbal and written communication skills and ability to work effectively in a team.
• Ability to adapt in a fast-paced, changing environment.
• Willingness to work shifts, including weekends and nights.
• Ability to work at heights greater than 4 feet and in environments that may necessitate respiratory protection.
• Ability to discern verbal cues and sit or stand for prolonged periods.
• Ability to ascend or descend ladders, scaffolding, ramps, or similar structures.
• Ability to move objects up to 33 pounds and perform repetitive tasks using wrists, hands, or fingers.
• Ability to bend, push or pull, reach to retrieve materials from 18 to 60 inches in height, and use twisting motions.
• May work in mechanical or production spaces requiring hearing protection and enrollment in a hearing conservation program.

Nice To Haves

• Associate degree in Life Sciences or a related field.
• Qualification in a support area, such as Formulation Buffer Prep, Media Prep, or DSM Buffer Prep, through internal or post-hire training.
• BioWorks or BTEC Capstone cGMP coursework.

Responsibilities

• Support operational-readiness activities for biopharmaceutical manufacturing.
• Assist with procedure review, document preparation, testing, commissioning, and equipment-readiness activities.
• Execute and document assigned manufacturing processing and support activities according to SOPs and cGMP requirements.
• Perform process monitoring and in-process testing, such as pH, conductivity, and visual inspections.
• Follow technical instructions and accurately document completed work.
• Complete and maintain all required training and qualifications.
• Work collaboratively with experienced associates, technical staff, and supervisors.
• Follow all safety, quality, and operational procedures.
• Perform other duties as assigned.

What This Job Offers

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