Overview

The Engineer/Scientist 3 will provide technology transfer support and technical oversight during manufacturing operations

External US

Major Accountabilities

• Leads and supports Upstream / Cell Culture Technology transfer sub-team activities
• Collaborates and leads execution of sampling protocols, as directed
• Participates in writing and reviewing master batch records (MBRs) and standard operating procedures (SOPs)
• Supports training of manufacturing staff
• Supports training members of the process sciences group on the use of equipment in the lab and pilot plant areas
• Analyzes and summarizes lab data for clients
• Writes process performance qualification (PPQ) protocols and reports
• Interprets and communicates results to the TT team
• Provides Upstream / Cell Culture technical support for troubleshooting, process assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to process deviations
• Writes reports and aids in closing out deviations
• Provides process training and consultation on topics related to manufacturing and process
• Provides input to technical risk assessments for new manufacturing processes
• Contributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at process monitoring and resolution of investigations
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support
• Supports continuous improvement projects, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and cost
• Manages lab equipment
• Collaborates with colleagues to develop lab scale protocols
• Executes and oversees sampling plans for lab runs
• Serves as on-call for lab issues and concerns
• Other duties, as assigned

Minimum Education and Experience Requirements

• Bachelor’s degree in Life Science or Chemical Engineering with 6 years of relevant work experience OR
• Master’s degree with 3 of relevant work experience.
• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment
• Prior drug substance and commercial manufacturing experience, including late stage process development, validation, and tech transfer

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.

PHYSICAL REQUIREMENTS

PHYSICAL DEMANDS

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

WORKING ENVIRONMENT

PHYSICAL DEMANDS

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

ENVIRONMENTAL CONDITIONS

Will work in warm/cold environments. X No Yes

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