• Engineer/Scientist 3

    Fujifilm (Holly Springs, NC)


    Position Overview

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

    Job Description

    What You’ll Do

    + Conducts lab and pilot plant experiments

    + Generates and coordinates execution 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 data-based decisions

    + Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor 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 problem-solving 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 8 years related work experience (e.g., manufacturing); or

    + Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 6 years of related work experience (e.g., manufacturing)

    + Master’s degree with 3 years of related work experience; or

    + PhD with no prior experience

    + Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)

    + Experience using risk management and RCA tools

    Preferred Requirements

    + 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

    + Ability to discern audible cues.

     

    _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._

     

    **Job Locations** _US-NC-Holly Springs_

    **Posted Date** _2 days ago_ _(12/18/2025 9:57 AM)_

    **_Requisition ID_** _2025-35792_

    **_Category_** _Engineering_

    **_Company (Portal Searching)_** _FUJIFILM Biotechnologies_