Drug Product Documentation Associate 2

Job Locations US-NC-Holly Springs
Posted Date 3 weeks ago(4/5/2024 10:57 AM)
Requisition ID
Company (Portal Searching)
FUJIFILM Diosynth Biotechnologies


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

The work we do at FDB 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 FDB 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.

External US

About This Role


This role as Manufacturing Support Associate 2 will provide reliable support to the Drug Product Manufacturing operations during the establishment of the facility and processes. This position will also support the creation of standard operating procedures, processes, trainings and documentation along with supporting tech transfer, batch planning, documentation updates and coordination of non-batch activities. This includes: Changeover, PMs, deviation management and audit preparation.


What You’ll Do

  • During the project phase, support operational readiness initiatives as well as site commissioning and qualification
  • Own and drive drug product operational readiness document plan, contribute to the preparation of standard operating processes(SOPs) and documentation packages as defined by the project plan
  • Participate in operational readiness project meetings and support factory acceptance testing (FAT) and site acceptance testing (SAT), as required
  • Actively participate in establishment of batch handling processes for Drug product manufacturing
  • Execute and drive minor projects and initiate change management requests, including optimization projects
  • Lead and guide shop floor deviation investigation from initiation through closure
  • Provide training and mentor of junior level team members
  • Perform other duties as assigned

Who You Are


You have strong verbal and written communication skills. You have knowledge from operational experience with formulation, filling and visual inspection processes and production equipment. You have knowledge of cGMP from a pharmaceutical production. You have the ability to adapt in a fast-paced environment, pivot and adjust plans accordingly. You have the ability to think critically and have superior problem-solving skills. You have experience with IT Systems (Office and ERP Systems).


Basic Requirements

  • High School Diploma or GED
  • 6 years of Direct Experience

Preferred Requirements

  • Associate’s Degree in Life Sciences or Engineering + 4 years of direct experience OR
  • BA/BS in Life Sciences or Engineering + 2 years of direct experience OR
  • Military experience of equivalence
  • Prior cGMP experience from a pharmaceutical production environment
  • Preferably operational experience with formulation, filling and visual inspection processes and production equipment
  • BioWorks or BTEC Capstone cGMP coursework preferred


FDBN is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class. If an accommodation to the application process is needed, please email FDBN_PNC@fujifilm.com.


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.


Will work in environment which may necessitate respiratory protection   X No             Yes
May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.            No X Yes  
Will work in environment operating a motor vehicle or Powered Industrial Truck.   X No             Yes              
Ability to discern audible cues.            No  X Yes
Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.             No  X Yes
Ability to ascend or descend ladders, scaffolding, ramps, etc.              No  X Yes
Ability to stand for prolonged periods of time.              No  X Yes  120 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
Ability to sit for prolonged periods of time.              No  X Yes  120 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers.            No  X Yes
Ability to operate machinery and/or power tools.             No  X Yes
Ability to conduct work that includes moving objects up to X pounds. X No             Yes  If yes,            10 lbs.             33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.             No  X Yes
Will work in warm/cold environments  X No             Yes             Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No             Yes
Will work in small and/or enclosed spaces.  X No             Yes
Will work in heights greater than 4 feet.  X No             Yes


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