Manufacturing Associate 4, Drug Product Filling (2nd Shift - 3PM-11:30PM)

Fujifilm•Holly Springs, NC

About The Position

The manufacturing associate in Drug Product Manufacturing will have a primary task for operation of filling line including all tasks related. This role will also support projects which influence manufacturing processes for DPM including training of others. This position will also support and assist in scheduling daily manufacturing activities for the team. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours or shift rotation.

Requirements

High School Diploma or GED
6+ years of direct experience in a manufacturing environment

Nice To Haves

Associate’s Degree + 4 years of direct experience in a cGMP manufacturing environment OR BA/BS + 2 years of direct experience in a cGMP manufacturing environment
Equivalent Military training or experience
Experience on specific unit operations (ex: Viral Filtration and Bulk Dispensing)
Understanding of manufacturing run cadence and order of shift activities
Knowledge of cGMP, safety and operational procedures
A high degree of knowledge and expertise of the operation of specific production equipment
Be exposed to an environment that may necessitate respiratory protection
Be exposed to noisy environments
Have a normal range of vision
Climb ladders and stairs of various heights
Experience prolonged sitting, standing, walking, bending, stooping and stretching throughout the shift, up to 12 hours
Use hand-eye coordination and manual dexterity sufficient to operate a computer keyboard, telephone, calculator, and other office equipment is required
May be required to lift up to 50 pounds on occasion

Responsibilities

During the project phase Participate and support testing activities, such as FAT, PQ etc. as well as other related activities
Support and contribute to the preparation of the documentation package as e.g., Standard Operating Procedures, Work Instructions
Contribute to the preparation for operational readiness related to bulk drug product manufacturing
Possible assignments include: Supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes as well as testing and commissioning support
Travel up to 0-25% (international or domestic) may be required during the project phase
In operations Lead, execute and document manufacturing processing steps and/or manufacturing support activities as well as process monitoring and control
Perform operations of the Drug product filling line
Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
Own the establishment of processes and trainings to become a trainer for coworkers
Maintain compliance of GMP documents and ensure own training level is complaint and maintained
Support and/or assist senior level associates or supervisor with scheduling daily activities on drug product manufacturing floor, as needed
This role requires shift work (weekend and potential for nights)
Perform other duties as assigned