Manufacturing Associates - Biologics (Multiple Openings - NIGHT SHIFT)

We have opportunities for Manufacturing Associates at several levels within our Drug Substance production teams .

These roles will execute manufacturing processing steps and associated activities when operational. You will also participate in operational readiness projects and commissioning/qualification projects. Our brand-new facility will be 24/7 operational. We will have a day shift and a night shift. We are hiring for night-specific roles; however, all roles may require flexibility with working hours and/or shift.

We operate on a 2-2-3, 12 hour shift schedule (days or nights).

• Please note that this posting represents multiple openings ***
  
  

Company Overview

Follow Your Genki to North America's largest, state-of-the-art Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more important—and we are looking for talented candidates to join us. We are growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FUJIFILM Diosynth Biotechnologies and help manufacture the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. We are proud to cultivate a culture that will fuel your passion, energy and drive - what we call Genki.

Join us

We are growing our locations and are investing more than $2 billion into establishing a new large-scale manufacturing site for biopharmaceuticals in the United States to accelerate the growth of our Bio CDMO (Contract and Development Manufacturing Organization) business. This will be the largest end-to-end cell culture CDMO provider in North America.

The new site will offer end-to-end solutions to our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture, it will also provide automated fill-finish and assembly, packaging, and labeling services. The new state-of-the-art facility is located in Holly Springs, North Carolina, United States.

Job Description

What You’ll Do

During the project phase, you may:

• Participate and support testing activities , such as : FAT, PQ etc.
• Support and contribute in the preparation of the documentation package ( i.e. Standard Operating Procedures and Work Instructions )
• Contribute to the preparation for operational readiness related to Weigh and Dispense, bulk D rug S ubstance or D rug P roduct manufacturing
• Possible assignments include , supporting projects related to procedure review and/or creation, development or transfer of manufacturing business processes, testing and commissioning support
  
  

Once we are operational, you may:

• Lead, execute and document manufacturing processing steps and/or manufacturing support activities, process monitoring and control
• Perform operations of functional area
• Execute validation protocols according to cGMP Standard Operating Procedures (SOPs)
• Own or establish processes and trainings to become a trainer for coworkers
• Maintain compliance of GMP documents and ensure your own training level is compl iant and maintained
• Support and/or assist senior level associates or supervisor with scheduling daily activities for your functional area , as needed
• This role requires shift work (weekend and potential for nights)
• Perform other duties as assigne d
  
  

Basic Requirements

• Manufacturing Associate 2
• High School Diploma or GED with 2 years of related experience in Life Sciences Manufacturing OR
• Associate's Degree with 0 years of related experience OR
• Equivalent Military training/experience
• Manufacturing Associate 3
• High School Diploma or GED with 4 years of related experience in Life Sciences Manufacturing OR
• Associate's Degree with 2 years of experience in Life Sciences Manufacturing OR
• BA/BS with 0 years of experience OR
• Equivalent Military training/experience
• Manufacturing Associate 4
• High School Diploma or GED with 6 years of experience in Life Sciences Manufacturing OR
• Associate degree with 4 years’ experience in Life Sciences Manufacturing OR
• BA/BS with 2 years of experience in Life Sciences Manufacturing OR
• Equivalent Military training/experience
• Manufacturing Associate 5
• High School Diploma or GED with 8 years’ experience in a Life Sciences Manufacturing environment OR
• Associate Degree with 6 years’ experience in a Life Sciences Manufacturing environment OR
• BA/BS, preferably in Life Sciences/Engineering with 4 years of experience in Life Sciences Manufacturing OR
• Equivalent Military Experience
  
  

Working Conditions & Physical Requirements

• Be exposed to a n 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.

EEO Information

Fujifilm is committed to providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department (FDBN_PNC@fujifilm.com).