• The Senior Engineer 1 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.

Major Accountabilities

• Develops and implements training for drug product manufacturing staff on new processes and procedures.
• Develops, implements, and leads training for drug product group on new procedures, the use of equipment in the MSAT lab.
• Leads troubleshooting and process impact assessments.
• Designs, implements, and analyzes lab data aimed at solving complex manufacturing problems.
• Provides interpretation of manufacturing data, analyze lab or manufacturing data to solve manufacturing problems.
• Leads execution of all aspects of process validation including ancillary process validation (small-scale studies), protocols and reports
• Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects.
• Provides engineering and scientific leadership to support clinical and commercial processes.
• Participate in process sub-teams throughout the phases of technology transfer (TT)
• Serves as subject matter expert (SME) to support TT stage gate reviews on incoming processes and changes to ensure readiness for introduction to Manufacturing, including acceptable process characterization and validation, risk assessments, mitigation, and robust supporting data for the
proposed changes.
• Provides comprehensive written manufacturing protocols and reports summarizing investigations, studies and projects.
• Develops process validation strategy and oversees execution of manufacturing process validation runs.
• Leads generation of sampling plans for process validation reports (PVRs) and investigations
• Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)
• As technical SME supports generation of master plans, contamination control strategy, extractable and leachable assessment, and other site procedures and policies.
• Generates and executes process training and consults on topics related to manufacturing and process.
• Leads technical risk assessments for new manufacturing processes.
• Oversees process monitoring and overall management of manufacturing data (i.e., databasing) and the statistical analysis aimed at both process monitoring and continued process verification.
• Writes and reviews documentation for internal and external use, such as manufacturing campaigns summary reports, process performance qualification (PPQ) protocols and reports, impact assessments, etc.
• Collaborates with the manufacturing department to support commercial and clinical manufacturing campaigns, including on-floor support.
• Leads continuous improvement projects, in partnership with manufacturing, Quality, Engineering, Global teams when applicable, to improve manufacturability, reliability, yield and cost,
• Deploys and maintains Large Scale Business Unit (LSBU) strategic roadmap for continuous and breakthrough improvements, and associated requirements.
• As technical SME provides supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions.
• Other duties, as assigned

Minimum Requirements

• Bachelor’s degree in in Engineering, Life Science or Chemical Engineering with 8 years of relevant experience (e.g., manufacturing); or

• Master’s degree with 6 years of experience; or
• PhD with 3 years of experience
• Experience using quality systems (e.g., deviation management system, change control, CAPA, document management system)

Preferred Requirements

• Experience working in a Good Manufacturing Practices (GMP) environment

• Prior drug product or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting
• Experience supporting or writing portions of regulatory findings

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 Range (If yes, specify approximate temperature ranges.)
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