Biotech Manufacturing Lead, cGMP 24/7 Ops

FUJIFILM; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Associate 4 to support execution and documentation of manufacturing activities in a 24/7 cGMP facility. The role emphasizes readiness for project phases and steady-state operations, with flexible hours and shift rotations.

The position requires a high school diploma or higher with related life sciences manufacturing experience, plus strong troubleshooting and documentation skills.

Qualifications

• Must have strong troubleshooting and technical documentation skills.
• Ability to train, guide, and provide technical support to 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.
• Perform other duties as assigned.

Skills

Troubleshooting

Technical documentation

Training others

Time management

Education

High school diploma or GED

Associate degree

Bachelor’s degree

Equivalent military training or experience

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Manufacturing Associate 4 to support execution and documentation of manufacturing activities in a 24/7 cGMP facility. The role emphasizes readiness for project phases and steady-state operations, with flexible hours and shift rotations.

The position requires a high school diploma or higher with related life sciences manufacturing experience, plus strong troubleshooting and documentation skills.