Engineer 2

The Upstream Engineer/Scientist 3 will provide tech transfer support and technical oversight for a largescale cell culture in monoclonal antibody manufacturing.

Follow Your Genki to North Americas largest stateoftheart Life Science Manufacturing Facility & CDMO

The work we do at FUJIFILM Diosynth Biotechnologies has never been more importantand we are looking for talented candidates to join us. We are growing our locations our capabilities and our teams and looking for passionate missiondriven people like you who want to make a real difference in peoples 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 newlargescale 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 endtoend cell culture CDMO provider in North America.

The new site will offer endtoend solutionsto our customers looking to manufacture biopharmaceuticals in the US. In addition to drug substance manufacture it will alsoprovideautomated fillfinish and assembly packaging and labeling services. The new stateoftheart facility is located in Holly Springs North Carolina United States.

What Youll Do

• Conducts lab and pilot plant experiments
• Generates and coordinates sampling protocols
• Serves as subject matter expert (SME) to lead and conduct troubleshooting process impact assessments and executes root cause analysis (RCA) and corrective and preventive action (CAPA) in response to deviations
• Executes and analyzes lab and pilot plant work aimed at solving complex manufacturing problems
• Leads and supports technology transfer (TT) across multiple unit operation
• Coordinates plans and executes manufacturing process validation runs
• Supports design and leads generation of sampling plans for process validation reports (PVRs) and investigations
• Writes and reviews master batch records (MBRs) and standard operating procedures (SOPs) as needed
• Generates and executes process training and consults on topics related to manufacturing and process
• Leads technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e. databasing) and the statistical analysis aimed at both process monitoring and continued process verification
• Writes documentation for internal and external use such as manufacturing campaigns summary reports process performance qualification (PPQ) protocol and reports impact assessments etc.
• Leads training of manufacturing staff and process sciences group on new processes procedures and use of equipment in the lab
• Interprets and utilizes new knowledge to promptly drive databased decisions
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns including onfloor support
• Leads continuous improvement projects within unit operations in partnership with manufacturing when applicable to improve manufacturability reliability yield and cost
• Supports supplier technical evaluations risk assessments and raw material evaluation and qualification
• Other duties as assigned

Knowledge and Skills

• Proficient knowledge in Design of Experience (DOE)
• Proficient knowledge in Statistical Process Control
• Effective communication both written and oral
• Ability to effective present information to others
• Proficient project management skills
• Advanced problemsolving skills
• Ability to provide feedback to others including leaders
• Ability to develop effective working relationships internally and externally
• Ability to adapt communication style to differing audiences and advise others on difficult matters

Basic Requirements

• Associate degree in Engineering Life Science or Chemical Engineering with 4 years of related work experience (e.g. manufacturing); or
• Bachelors degree in Engineering Life Science or Chemical Engineering with 2 years of related work experience (e.g. manufacturing); or
• Masters degree with no prior experience
• Experience using quality systems (e.g. deviation management change control CAPA document management system)
• Experience in contract manufacturing or interacting with contract manufacturers

Preferred Requirements

• Associate degree in Engineering Life Science or Chemical Engineering with 8 years related work experience (e.g. manufacturing); or
• Bachelors degree in in Engineering Life Science or Chemical Engineering with 6 years of related work experience (e.g.
  manufacturing)
• Masters degree with 3 years of related work experience; or
• PhD with no prior experience
• Large scale manufacturing experience with CHO cell processes/monoclonal antibody production
• Experience using risk management and RCA tools
• Experience in contract manufacturing or interacting with contract manufacturers
• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance and manufacturing experience including process development validation and transfer

WORKING CONDITIONS & PHYSICAL REQUIREMENTS

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. X No 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. X No Yes

Ability to ascend or descend ladders scaffolding ramps etc. X No Yes
Ability to stand for prolonged periods of time. X No Yes
Ability to sit for prolonged periods of time. X No Yes
Ability to conduct activities using repetitive motions that include writs hands and/or fingers. X No Yes
Ability to operate machinery and/or power tools. X No 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. X No Yes

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 viaemail 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.

Fujifilm is committedto 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.

If you require reasonable accommodation in completing this application interviewing completing any preemployment testing or otherwise participating in the employee selection process please direct your inquiries to our HR Department .