Welcome page Returning Candidate? Log back in! Engineer / Scientist 2/3, Downstream - MSAT Job Locations US-NC-Holly Springs Posted Date 19 hours ago(7/31/2025 5:27 PM) Requisition ID 2025-35180 Category Engineering Company (Portal Searching) FUJIFILM Biotechnologies Position Overview

The Engineer / Scientist 2/3, Downstream MSAT will provide tech transfer support and technical oversight for large scale purification activities for Monoclonal antibody production.

Job Description

What You’ll Do

Conducts lab and pilot plant experimentsGenerates and coordinates execution sampling protocolsServes 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 deviationsExecutes and analyzes lab and pilot plant work aimed at solving complex manufacturing problemsLeads and supports technology transfer (TT) across multiple unit operationCoordinates, plans, and executes manufacturing process validation runsSupports design and leads generation of sampling plans for process validation reports (PVRs) and investigationsWrites and reviews master batch records (MBRs) and standard operating procedures (SOPs), as neededGenerates and executes process training and consults on topics related to manufacturing and processLeads technical risk assessments for new manufacturing processesContributes to the management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verificationWrites 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 labInterprets and utilizes new knowledge to promptly drive data-based decisionsCollaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor supportLeads continuous improvement projects within unit operations, in partnership with manufacturing when applicable, to improve manufacturability, reliability, yield and costSupports supplier technical evaluations, risk assessments, and raw material evaluation and qualificationOther duties, as assigned

Knowledge and Skills

Proficient knowledge in Design of Experience (DOE)Proficient knowledge in Statistical Process ControlEffective communication, both written and oralAbility to effective present information to othersProficient project management skillsAdvanced problem-solving skillsAbility to provide feedback to others, including leadersAbility to develop effective working relationships internally and externallyAbility 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

• Bachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of related work experience (e.g., manufacturing); or• Master’s degree with no prior experience• Experience using quality systems (e.g., deviation management, change control, CAPA, document management system)

 

Preferred Requirements

Associate degree in Engineering, Life Science or Chemical Engineering with 8 years related work experience (e.g., manufacturing); orBachelor’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; orPhD with no prior experienceLarge scale manufacturing support experience with chromatography for several types of chromatographic mediums operations, viral 
filtration, ultrafiltration, and bulk filling, troubleshooting, and deviation supportExperience using quality systems (e.g., deviation management  system, change control, CAPA, document management system)Experience using risk management and RCA tools

 

 

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

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