Manufacturing Associate 2, Visual Inspection (1st Shift)

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 well open North Americas largest end-to-end CDMO biopharmaceutical manufacturing facility offering drug substance production fill-finish and packaging under one roof.

Were 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 were proud to cultivate a culture that will fuel your purpose energy and drivewhat we call Genki. Ready to shape the future of medicine Lets transform healthcare together!

Holly Springs North Carolina combines small-town warmth with proximity to Raleighs thriving tech scene making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70000 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: Description

About Us

We are a growth-focused biomanufacturing organization committed to operational excellence patient safety and a culture of continuous improvement. Our team members:

• 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 025% (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 youll 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

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 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.

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 ().

Required Experience:

IC