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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 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 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); 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

+ Large scale manufacturing support experience with chromatography for several types of chromatographic mediums operations, viral filtration, ultrafiltration, and bulk filling, troubleshooting, and deviation support

+ Experience 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

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

**Posted Date** _1 day ago_ _(7/31/2025 5:27 PM)_

**_Requisition ID_** _2025-35180_

**_Category_** _Engineering_

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