Manufacturing Associate , Column Packing

Position: Manufacturing Associate 3, Column Packing
** Position Overview*
* Build life-changing medicines with a team that trusts you to lead on the manufacturing floor. As a Manufacturing Associate 3 (Drug Substance Manufacturing), you'll take ownership of critical processing steps, help bring new capacity online, and keep a 24/7 operation running safely, compliantly, and on time. If you thrive in hands-on, fast-paced environments and enjoy guiding others, this is your next step.

** 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:

** Job Description*
* About Us

+ We are a 24/7 biopharmaceutical manufacturing facility focused on bulk drug substance (Drug Substance Manufacturing, DSM).

+ Our teams partner across functions to ensure safe, reliable, and compliant production in accordance with current Good Manufacturing Practices (cGMP).

+ We value curiosity, teamwork, and continuous improvement, and we welcome people from all backgrounds to grow their careers with us.

Responsibilities Project phase (operational readiness)

+ Contribute to readiness for bulk drug substance manufacturing (systems, equipment, and documentation).

+ Support projects such as:

+ Reviewing and creating procedures.

+ Developing or transferring manufacturing business processes.

+ Supporting equipment and system testing and commissioning.

+ Travel up to 0-25% (domestic or international) may be required during the project phase.

In operations

+ Lead, execute, and document manufacturing processing steps and/or manufacturing support activities, including process monitoring and control.

+ Perform in‑process testing (for example: pH, conductivity, visual inspection).

+ Execute validation protocols in alignment with cGMP Standard Operating Procedures (SOPs).

+ Maintain all required training to perform assigned manufacturing activities.

+ Assist with and/or lead cycle counts; manage materials for the assigned manufacturing area.

+ Work shifts that include weekends and may include nights, in support of a 24/7 operation.

+ Perform other duties as assigned.

Minimum qualifications

+ Education and experience (one of the following):

+ High school diploma or GED and 4 years of related experience in a manufacturing environment; or

+ Associate's degree; or

+ Bachelor's degree (BA/BS), preferably in Life Sciences or Engineering; or

+ Associate's degree plus 2 years of related experience in a cGMP manufacturing environment; or

+ Equivalent military training or experience.

+ Qualified experience in at least one unit operation:

+ DPFG Filler; or

+ Cell Culture - Seed Train.

+ Knowledge, skills, and abilities:

+ Ability to assist in troubleshooting.

+ Strong verbal and written communication skills.

+ Knowledge of production equipment operation relevant to assigned unit operations.

+ Basic understanding of manufacturing run cadence and the order of shift activities.

+ Knowledge of cGMP, safety, and operational procedures.

+ Ability to work effectively in a team environment.

+ Exercises considerable judgment and initiative; determines methods and procedures on new assignments; may act as an informal team leader.

Preferred qualifications

+ Bio Works or BTEC Capstone cGMP coursework.

Physical requirements and working environment

+ May require respiratory protection.

+ May work in mechanical/production spaces requiring hearing protection and participation in a hearing conservation program.

+ May operate a motor vehicle or Powered Industrial Truck (PIT).

+ Ability to discern audible cues.

+ Ability to inspect/perform tasks with 20/20 corrected vision, including color distinction.

+ Ability to ascend/descend ladders, scaffolding, ramps, etc.

+ Ability to stand and sit for prolonged periods.

+ Ability to perform repetitive motions (wrists, hands, and/or fingers).

+ Ability to operate machinery and/or power tools.

+ Ability to move objects up to 33 lbs.

+ Ability to bend, push/pull, and reach to retrieve materials from 18" to 60" in height, using twisting motions.

+

Environmental conditions:

+ Not routinely exposed to warm/cold extremes, outdoor elements, or…