The role as Manufacturing Associate 2 will execute and document manufacturing processing activities within a cGMP environment. This manufacturing facility will be 24/7 operational and the role may require to be flexible with working hours and shift rotation.

What You’ll Do

During Project Phase:

• Contribute 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:

• Execute and document manufacturing processing steps and/or manufacturing support activities; process monitoring and control
• Perform in-process testing (pH, conductivity, visual inspection)
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)

• This role requires shift work (weekend and potential for nights)

• Maintain training to perform all required activities  
• Perform all other duties as assigned

Who You Are

You have knowledge of the operations of support process equipment. You have an understanding of a cGMP environment, safety and operational procedures. You have the ability to perform operations and document them accurately. You have the ability to follow technical instructions and document them. You have strong verbal and written communication skills. You have the ability to work closely and effectively in a team environment. You have the ability to adapt in a fast-paced changing environment.

Basic Requirements

• High School Diploma or GED
• 2 years of related experience

Preferred Requirements

• Associate’s Degree, preferably in Life Sciences or similar
• 2 Years of direct experience in a cGMP manufacturing environment
• 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.