Manufacturing Associate 2 - Downstream (Day Shift) at FUJIFILM

Manufacturing Associate 2

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

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 drivewhat 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."

Job Description

Major Accountabilities:

During the project phase,

• Contributes to the preparation for operational readiness related to bulk drug substance manufacturing.
• Possible assignments include supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support.
• Travel up to 0?25% (international or domestic) may be required.

In operations

• Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control.
• Performs in?process testing (pH, conductivity, visual inspection)
• Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Maintains training to perform all required activities.
• This role requires shift work (weekend and potential for nights).
• Performs other duties as assigned

Knowledge, Skills and Abilities:

• Knowledge of the operation of support process equipment
• Understanding of cGMPs, safety and operational procedures
• Ability to perform operations and document them accurately.
• Ability to follow technical instructions and document them.
• Ability to work closely and effectively in a team environment.
• Strong verbal and written communication skills
• Ability to adapt in a fast?paced changing environment

Minimum Education and Experience Requirements:

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

Preferred Education and Experience:

• Associate degree, preferably in Life sciences or similar
• 2 years + direct experience in cGMP manufacturing environment
• Internal or after training: Qualified on a support area (i.e. Formulation Buffer Prep, Media Prep or DSM Buffer prep)
• BioWorks or BTEC Capstone cGMP coursework preferred.

Physical Demands and Working Environment:

• Will work in environment which may necessitate respiratory protection
• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Ability to discern verbal cues.
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time.
• Ability to sit for prolonged periods of time.
• Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
• Ability to conduct work that includes moving objects up to 33 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in heights greater than 4 feet.

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 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.