FUJIFILM Holdings America Corporation · 1 month ago
Sr Engineer 2/Scientist 2 (Upstream)
US-NC-Holly Springs
Full-time
Onsite
Senior Level
5+ years expFUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. The Senior Engineer/Scientist 2 will serve as a subject matter expert and provide technology transfer support and technical oversight during manufacturing operations.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
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
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 Holdings America Corporation
For over 90 years, Fujifilm has found #ValueFromInnovation through expanding its portfolio to represent a broad spectrum of industries including medical and life sciences, electronic, chemical, graphic arts, information systems, industrial products, broadcast, data storage, and photography.
10001+ employees
H1B Sponsorship
FUJIFILM Holdings America Corporation 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2022 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2006-06-13Acquired
Leadership Team
Deepak Mahulikar
Chief Technology Officer
Patrícia Colombo
Chief Compliance Officer
Company data provided by crunchbase