Senior Manufacturing Associate, cGMP Biotech

NCBioImpact; Holly Springs (NC); On-site; USD 55,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is hiring a Manufacturing Associate 4 to execute and document manufacturing processing activities in a cGMP environment, supporting readiness and steady-state operations in a 24/7 facility with rotating shifts.

You will perform complex production tasks, ensure SOP and cGMP compliance, assist with equipment testing and validation, and train less-experienced teammates while escalating safety or quality concerns.

Qualifications

• Minimum 6 years life sciences manufacturing with high school diploma or GED, OR 4 years with an associate, OR 2 years with a bachelor’s degree, OR equivalent military training.
• Demonstrated troubleshooting and documentation skills.
• Ability to train and support other associates.
• Advanced understanding of manufacturing cadence and shift activities.

Responsibilities

• Lead and execute complex manufacturing processing and support activities within an assigned functional area.
• Ensure manufacturing activities are completed and documented according to SOPs and cGMP requirements.
• Support operational readiness, process transfer, procedure creation, equipment testing, commissioning, and validation.
• Perform process monitoring and in-process testing.
• Assist with cycle counts and materials management.
• Guide and train less-experienced manufacturing associates.
• Lead or support troubleshooting of manufacturing and operational issues.
• Support senior associates and supervisors with coordinating daily floor activities.
• Provide advanced equipment and process knowledge within qualified unit operations.
• Identify potential safety, quality, documentation, or operational concerns and escalate them appropriately.

Skills

Troubleshooting

Documentation

Cadence/Shift knowledge

Production equipment

Time management

Education

High school diploma or GED

Associate degree

Bachelor’s degree

Equivalent military training

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is hiring a Manufacturing Associate 4 to execute and document manufacturing processing activities in a cGMP environment, supporting readiness and steady-state operations in a 24/7 facility with rotating shifts.

You will perform complex production tasks, ensure SOP and cGMP compliance, assist with equipment testing and validation, and train less-experienced teammates while escalating safety or quality concerns.