Manufacturing Associate 4, Visual Inspection (2nd Shift 3pm to 11:30pm)

Fujifilm•Holly Springs, NC

11d•Onsite

About The Position

The Manufacturing Associate 4 works in Drug Product Manufacturing and primarily operates the filling line and performs related tasks. The role also supports projects that affect manufacturing processes, helps train coworkers, and assists with scheduling daily manufacturing activities. The facility operates 24/7, and the position may involve flexible hours or shift rotation. The stated schedule is second shift, 3:00 p.m. to 11:30 p.m.; the role also requires shift work and may include weekends and nights. During the project phase, the associate supports testing activities such as FAT and PQ, helps prepare documentation including Standard Operating Procedures and Work Instructions, and contributes to operational readiness for bulk drug product manufacturing. Possible assignments include procedure review or creation, development or transfer of manufacturing business processes, and testing and commissioning support. Domestic or international travel of up to 0–25% may be required during this phase. In operations, the associate leads, executes, and documents manufacturing processing steps and support activities; monitors and controls processes; operates the Drug Product filling line; and executes validation protocols according to cGMP SOPs. The role owns the establishment of processes and training to become a trainer for coworkers, maintains GMP document compliance and required training, and may assist senior associates or supervisors with scheduling daily activities on the manufacturing floor. The position is based onsite in Holly Springs, North Carolina. Work may involve respiratory protection, noisy environments, climbing ladders and stairs, prolonged sitting, standing, walking, bending, stooping, and stretching during shifts of up to 12 hours, and occasionally lifting up to 50 pounds. Normal vision and sufficient hand-eye coordination and manual dexterity to operate office equipment are required.

Requirements

High school diploma or GED.
At least 6 years of direct experience in a manufacturing environment.
Knowledge of cGMP, safety, and operational procedures.
A high degree of knowledge and expertise operating specific production equipment.
Ability to work shifts; the role may involve weekends and nights.
Ability to meet the stated physical and work-environment requirements, including climbing, prolonged movement or standing, and occasionally lifting up to 50 pounds.

Nice To Haves

Associate degree plus 4 years of direct experience in a cGMP manufacturing environment, or a BA/BS plus 2 years of direct experience in a cGMP manufacturing environment.
Equivalent military training or experience.
Experience with specific unit operations, such as viral filtration and bulk dispensing.
Understanding of manufacturing run cadence and the order of shift activities.
Experience supporting FAT, PQ, validation, testing, commissioning, or manufacturing-process development and transfer.

Responsibilities

Operate the Drug Product filling line and perform related tasks.
Lead, execute, and document manufacturing processing steps and manufacturing support activities, including process monitoring and control.
Execute validation protocols according to cGMP Standard Operating Procedures.
Support project testing activities, including FAT and PQ, and related activities.
Support preparation of documentation packages, including Standard Operating Procedures and Work Instructions.
Contribute to operational readiness for bulk drug product manufacturing.
Support procedure review or creation, development or transfer of manufacturing business processes, and testing and commissioning activities as assigned.
Establish processes and training to become a trainer for coworkers.
Maintain compliance of GMP documents and ensure personal training is current and maintained.
Assist senior associates or supervisors with scheduling daily manufacturing activities as needed.
Support projects that influence manufacturing processes and train others.
Perform other duties as assigned.