Manufacturing Associate 4, Visual Inspection (2nd Shift 3pm to 11:30pm)
About The Position
The Manufacturing Associate 4 works in Drug Product Manufacturing, with primary responsibility for operating the filling line and performing related tasks. The role supports manufacturing-process projects, training, and scheduling daily activities for the team. During the project phase, the associate supports testing, documentation, and operational readiness for bulk drug product manufacturing. In operations, the associate leads and documents manufacturing and support activities, performs filling-line operations, executes validation protocols, and helps establish processes and coworker training. The facility operates 24/7; this position is on second shift and requires shift work, including weekends and potentially nights. Flexibility with working hours or shift rotation may be required. Travel of 0–25% may be required during the project phase.
Requirements
- High school diploma or GED.
- At least 6 years of direct experience in a manufacturing environment.
- Ability to work shifts, including weekends and potentially nights.
- Ability to travel 0–25% during the project phase, domestically or internationally, if required.
- Ability to meet the stated physical and working-condition requirements, including occasional lifting up to 50 pounds.
Nice To Haves
- Associate’s degree and 4 years of direct experience in a cGMP manufacturing environment, or a BA/BS and 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.
- Knowledge of cGMP, safety, and operational procedures.
- High degree of knowledge and expertise in operating specific production equipment.
Responsibilities
- Participate in and support testing activities, including FAT and PQ, and related activities.
- Support preparation of documentation, including Standard Operating Procedures and Work Instructions.
- Contribute to operational readiness for bulk drug product manufacturing.
- Support projects involving procedure review or creation, development or transfer of manufacturing business processes, and testing and commissioning.
- Lead, execute, and document manufacturing processing steps and manufacturing support activities, including process monitoring and control.
- Operate the Drug Product filling line.
- Execute validation protocols according to cGMP Standard Operating Procedures.
- Establish processes and trainings and become a trainer for coworkers.
- Maintain compliance of GMP documents and keep personal training current and compliant.
- Support or assist senior-level associates or a supervisor with scheduling daily manufacturing-floor activities as needed.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
