Manufacturing Associate 2, Upstream/Downstream
About The Position
The Manufacturing Associate 2 supports reliable, compliant biopharmaceutical manufacturing by executing and documenting manufacturing processing and support activities in a cGMP environment. The role contributes to project-phase readiness and steady-state operations at a 24/7 facility, helping maintain safe, consistent, and efficient production. Flexibility with working hours and shift rotations is required. The associate supports operational-readiness activities, including procedure review, document preparation, testing, commissioning, and equipment readiness. They perform process monitoring and in-process testing, follow technical instructions, maintain accurate documentation, and complete required training and qualifications. Work is carried out collaboratively with experienced associates, technical staff, and supervisors while following safety, quality, and operational procedures. The position is based at FUJIFILM Biotechnologies’ biopharmaceutical manufacturing facility in Holly Springs, North Carolina. The work environment may include production or mechanical spaces, heights greater than four feet, respiratory protection requirements, and hearing protection requirements.
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 and flexibility to work shifts in a 24/7 environment, including weekends and nights.
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, including 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
