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FUJIFILM Biotechnologies · 11 hours ago

Sr Engineer/Scientist 1 (Downstream)

Holly Springs, NC

Full-time

Onsite

Senior Level

6+ years exp

FUJIFILM Biotechnologies is seeking a Senior Engineer/Scientist 1 to provide technology transfer support and technical oversight during manufacturing operations. The role involves leading training, troubleshooting, and process validation while providing engineering and scientific leadership to support clinical and commercial processes.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Provides oversight on lab and pilot plant activities and guides implementation of process parameters or controls for manufacturing processes

Develops and implements training for manufacturing staff on new processes and procedures

Develops, implements, and leads training for Process Science (PS) group on new procedures, the use of equipment in the PS lab and pilot plant areas, and Good Manufacturing Practices (cGMP) systems and practices

Leads troubleshooting, process impact assessments, and execution of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations, as needed

Designs, implements, and analyzes lab and pilot plant work 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

Leads 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

Qualification

Process validationManufacturing PracticesTechnical risk assessmentsManufacturing data analysisTraining developmentRoot cause analysisEngineering leadershipContinuous improvementCollaborationDocumentation writing

Required

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

Master's degree with 6 years of experience

PhD with 3 years of experience

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

Preferred

Experience working in a Good Manufacturing Practices (GMP) environment

Prior drug substance or manufacturing experience, including process validation, transfer, commercialization, and manufacturing support and troubleshooting

Experience supporting or writing portions of regulatory findings

Company

FUJIFILM Biotechnologies

Glassdoor3.4

For over 30 years, FUJIFILM Biotechnologies' mission has been advancing tomorrow’s medicine.

Founded in 2011

Morrisville, North Carolina, USA

1001-5000 employees

https://fujifilmbiotechnologies.fujifilm.com/

H1B Sponsorship

FUJIFILM Biotechnologies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2021 (1)