MSAT Engineer 3 - Drug Product

Overview

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

External US

Major Accountabilities

• 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

 

Minimum Requirements

• 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 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 product and manufacturing experience, including 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 REQUIREMENTSPHYSICAL DEMANDSWill work in environment which may necessitate respiratory protection X No YesMay 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 YesAbility to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color. X No YesWORKING ENVIRONMENTPHYSICAL DEMANDSAbility to ascend or descend ladders, scaffolding, ramps, etc. X No YesAbility 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 YesAbility to operate machinery and/or power tools. X No YesAbility 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 YesENVIRONMENTAL CONDITIONSW