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FUJIFILM Biotechnologies · 4 hours ago

Sr Engineer 2/Scientist 2 (Upstream)

Holly Springs, NC

Full-time

Onsite

Senior Level

5+ years exp

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Senior Engineer/Scientist 2 will serve as a subject matter expert, providing technology transfer support and technical oversight during manufacturing operations.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Develops site technical training programs for new processes and procedures

Collaborates with cross-functional teams 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

Serves as subject matter expert (SME) to support and lead technology transfer (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

As technical SME, provides supplier technical evaluations, risk assessments, raw material evaluation and qualification and experimental plans, as required

Identifies opportunities to improve systems and practices and provides direction to local and global cross-functional teams

Leads one or more projects spanning multiple departments and cross-functional areas

Provides engineering and scientific leadership to support program design, capital expenditure (CAPEX), and clinical or commercial processes

Leads process sub-teams throughout the phases of TT

Develops project plans, timelines, and communication forums to ensure a smooth transfer

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

Leads the execution of all aspects of process validation including ancillary process validation (both at-scale and small-scale studies), process performance qualification (PPQ), and continued process verification, validation master plans, risk assessments, protocols and reports

Writes, reviews, and approves master batch records (MBRs) and standard operating procedures (SOPs)

As technical SME, leads 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 and facilitates technical risk assessments for new manufacturing processes

Provides interpretation of manufacturing data, with advanced statistical techniques to interpret trending and resolve investigations

Leads and coordinates analysis of manufacturing process performance and reporting to manufacturing management

Supports development of longer-term Large-Scale Business Unit (LSBU) strategic design for continuous and breakthrough improvements, in collaboration with Process Development, client, and site leadership team

Delivers documentation for internal and external use, such as comprehensive written manufacturing protocols and reports, PPQ protocol and reports, summarizing investigations, impact assessments, studies, and projects

Other duties, as assigned

Qualification

Process ValidationProject ManagementQuality SystemsManufacturing PracticesRoot Cause AnalysisRisk AssessmentStatistical TechniquesTraining DevelopmentTechnical Leadership

Required

Bachelor's degree in Engineering, Life Science or Chemical Engineering with 12 years of relevant experience (e.g., manufacturing); or PhD with 5 years of experience

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

Experience with facilitating and training others on RCA and risk assessment

Project Management experience

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 authoring Investigational New Drug (IND) or Biologics License Application (BLA) sections

Prior authorship of Chemistry, Manufacturing and Control (CMC) sections for 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)