Manufacturing Associate 2, Upstream/Downstream

Fujifilm; Holly Springs (NC); Presencial; USD 42 000 - 65 000; Tempo integral

Resumo da oferta

FUJIFILM Biotechnologies in Holly Springs, North Carolina, is hiring Manufacturing Associate 1 and 2 to support biopharmaceutical manufacturing in a 24/7, cGMP environment. The role emphasizes accurate documentation, procedure reviews, and process readiness as part of steady-state operations.

The position requires flexibility with shifts and collaboration with experienced teams to ensure safety, quality, and regulatory compliance.

Qualificações

• 0–2 years of work experience.
• Basic knowledge of assigned process equipment.
• Ability to follow technical instructions and document accurately.
• Willingness to work shifts, including weekends/nights.
• Safety-focused and compliant with cGMP requirements.

Responsabilidades

• Support operational-readiness activities for biopharmaceutical manufacturing.
• Assist with procedure review, document preparation, testing, commissioning, and equipment-readiness activities.
• Execute and document 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.

Conhecimentos

cGMP knowledge

Documentation accuracy

Teamwork

Safety procedures

Shift flexibility

Formação académica

High School Diploma or GED

Associate degree (preferred)

Ferramentas

BioWorks

Descrição da oferta de emprego

Position Overview

Help deliver reliable, compliant biomanufacturing. We are hiring a Manufacturing Associate 1 and 2 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

• 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.

Manufacturing Associate 1 Minimum Qualifications:

• High School Diploma or GED
• 0–2 years of work experience.
• Flexibility to work shifts in a 24/7 environment.
• Basic knowledge of assigned process equipment.
• Basic understanding of cGMPs, safety, and operational procedures.
• Ability to follow technical instructions and document accurately using good documentation practices.
• Ability to assist with operations, learn quickly, ask questions, and work effectively in a team.
• Willingness to work shifts (including weekends/nights).

Manufacturing Associate 1 Preferred Qualifications:

• Associate degree, preferably with 1–2 years of direct experience in a cGMP manufacturing environment.
• BioWorks or BTEC Capstone cGMP coursework (preferred if no prior GMP experience).

Manufacturing Associate 2 Minniumum Qualifications

• High School Diploma or GED AND 2 years of related experience (or equivalent combination of education and experience).
• 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; ability to follow technical instructions.
• Strong verbal and written communication; ability to work effectively in a team.
• Ability to adapt in a fast-paced, changing environment.
• Willingness to work shifts (including weekends/nights).

Manufacturing Associate 2 Preferred Qualifications:

• Associate degree in Life Sciences or a related field.
• Qualified in a support area (e.g., Formulation Buffer Prep, Media Prep, or DSM Buffer Prep) through internal or post‑hire training.
• BioWorks or BTEC Capstone cGMP coursework.

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.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

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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]).