Manufacturing Associate 2 - Upstream (Night Shift)

Fujifilm•Holly Springs, NC

1d•Onsite

About The Position

The Manufacturing Associate 2 executes and documents manufacturing processing activities per cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

Requirements

Knowledge of the operation of support process equipment
Understanding of cGMPs, safety and operational procedures
Ability to perform operations and document them accurately.
Ability to follow technical instructions and document them.
Ability to work closely and effectively in a team environment.
Strong verbal and written communication skills
Ability to adapt in a fast‐paced changing environment
High School Diploma or GED and 2 years of related experience

Nice To Haves

Associate degree, preferably in Life sciences or similar
2 years + direct experience in cGMP manufacturing environment
Internal or after training: Qualified on a support area (i.e.
Formulation Buffer Prep, Media Prep or DSM Buffer prep)
BioWorks or BTEC Capstone cGMP coursework preferred.

Responsibilities

During the project phase,
Contributes to the preparation for operational readiness related to bulk drug substance manufacturing.
Possible assignments include supporting projects related to, procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
Travel up to 0‐25% (international or domestic) may be required.
In operations
Executes and documents manufacturing processing steps and/or manufacturing support activities, process monitoring and control.
Performs in‐process testing (pH, conductivity, visual inspection)
Executes validation protocols according to cGMP Standard Operating Procedures (SOPs)
Maintains training to perform all required activities.
This role requires shift work (weekend and potential for nights).
Performs other duties as assigned