Manufacturing Associate 2, Visual Inspection (1st Shift)

Fujifilm; Holly Springs (NC); Presencial; USD 52 000 - 78 000; Tempo integral

Resumo da oferta

FUJIFILM Biotechnologies in Holly Springs, NC, is hiring for a cGMP manufacturing role focused on executing and documenting critical drug product manufacturing activities in a 24/7 facility. The role emphasizes meticulous documentation, safety, teamwork, and compliance with SOPs.

The candidate will support startup and routine operations, including testing, validation, and training maintenance, with travel up to 25% as needed.

Qualificações

• High school diploma or GED required.
• 2 years of related manufacturing experience.
• Associate degree and cGMP coursework preferred.

Responsabilidades

• During project/startup phases: contribute to operational readiness, assist with procedure review/creation, help develop or transfer manufacturing processes, travel up to 0–25% as needed.
• In routine operations: execute and document manufacturing steps in a cGMP environment, monitor processes per SOPs, perform in-process testing, execute validation protocols, maintain training, work a shift after startup (24/7), perform other duties as assigned.

Conhecimentos

cGMP knowledge

Documentation

Teamwork

Communication

Safety awareness

Formação académica

High School Diploma or GED

Associate degree in Life Sciences

Descrição da oferta de emprego

Position Overview

Help bring critical therapies to patients by executing and documenting cGMP manufacturing activities in a state-of-the-art, 24/7 facility. If you thrive in a team environment, are meticulous about documentation and safety, and enjoy hands-on work with meaningful purpose, this role is for you.

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

About Us

• Collaborate across functions to deliver high-quality drug product reliably and safely
• Embrace cGMP standards and robust training to maintain compliance
• Value inclusivity, respect, and diverse perspectives to drive better outcomes
• Invest in learning and professional development to build strong, sustainable careers

Responsibilities

During project/startup phases:

• Contribute to operational readiness for drug product manufacturing
• Support procedure review and/or creation; help develop or transfer manufacturing business processes
• Assist with testing and commissioning activities to bring equipment and processes online
• Travel up to 0-25% (domestic or international) as needed

In routine operations:

• Execute and accurately document manufacturing processing steps and/or manufacturing support activities in a cGMP environment
• Monitor and control processes in accordance with Standard Operating Procedures (SOPs)
• Perform in-process testing (including pH, conductivity, and visual inspection)
• Execute validation protocols per cGMP SOPs
• Maintain all required training and qualifications for assigned activities
• Work a shift schedule after startup (includes weekends and potential nights) in a 24/7 operational facility
• Perform other duties as assigned to support team and business needs

What you'll bring to the team:

• Knowledge of support process equipment operation
• Understanding of cGMPs, safety, and operational procedures
• Ability to follow technical instructions and document operations accurately
• Strong teamwork, communication (verbal and written), and adaptability in a fast-paced environment
• Sound judgment to resolve moderately difficult assignments with minimal daily instruction

Minimum Qualifications (must have)

• High School Diploma or GED
• 2 years of related experience

Preferred Qualifications

• Associate degree, preferably in Life Sciences or similar
• 2+ years of direct experience in a cGMP manufacturing environment
• BioWorks or BTEC Capstone cGMP coursework

Physical Requirements and Working Environment

• May require use of respiratory protection; may require hearing protection and participation in a hearing conservation program
• Ability to discern audible cues
• Ability to ascend/descend ladders, scaffolding, ramps, etc.
• Ability to stand and sit for prolonged periods
• Ability to perform repetitive motions with wrists, hands, and/or fingers
• Ability to lift and move objects up to 33 lbs
• May work at heights greater than 4 feet
• Does not require operating a motor vehicle or powered industrial truck as a regular duty

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gen