What You’ll Do
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).
- Perform other duties as assigned
Basic Requirements
- High School Diploma or GED and 2 years of related experience
Preferred Requirements
- 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.
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
- 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
To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.