FUJIFILM Holdings America Corporation · 1 month ago
Engineer/Scientist 2 Material Science
US-NC-Holly Springs
Full-time
Onsite
Entry, Mid Level
2+ years expFUJIFILM Holdings America Corporation is seeking an Engineer or Scientist 2 in Material Science to support the design of new single-use consumables. The role involves assisting with leachable and extractables programs, supporting manufacturing investigations related to material science, and writing comprehensive reports.
Artificial Intelligence (AI)Machine LearningMotion CapturePhotographyPrinting
Responsibilities
Supports the team with the introduction of new raw materials, and associated document requirements
Assesses vendor change notifications, and provides input on raw materials related matters
Supports change requests for introduction, modification, and discontinuation of raw materials
Provides support between Quality Control (QC), Supply Chain, Manufacturing, and Quality to assess material and supplier risks (e.g., supplier technical evaluations, risk assessments, raw material evaluation and qualification, and new product introductions)
Support troubleshooting, process impact assessments, and facilitation of root cause analysis (RCA) and corrective and preventive action (CAPA) in response to critical deviations related to materials used in manufacturing, as needed
Delivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projects
Supports process sub-teams throughout the phases of technology transfer (TT)
Supports TT stage gate reviews on incoming processes and manufacturing readiness (e.g., acceptable process material evaluations, risk assessments, mitigation, and robust supporting data for the proposed changes)
Provides comprehensive written manufacturing reports summarizing investigations, studies and projects
Supports generation of sampling plans for process validation reports (PVRs) and investigations
Collaborates with the Manufacturing department to support commercial and clinical manufacturing campaigns, investigate materials issues, and implement necessary changes
Assists continuous improvement projects, in partnership with Manufacturing, Quality, Engineering, and global teams to improve manufacturability, reliability, yield and cost
Assists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectives
Other duties, as assigned
Qualification
Required
Bachelor's degree in Engineering, Life Science or Chemical Engineering with 2 years of applicable industry experience; OR
Master's degree in Engineering, Life Science or Chemical Engineering with no relevant experience
Experience working in a Good Manufacturing Practices (GMP) environment
Builds connections with key contacts within the department and outside specialty
Communicates effectively within the team
Engages in important conversations with cross-functional team members
Develops basic hypotheses for projects
Possesses fundamental project management skills. Effectively communicates information to others
Thinks critically and self-directed with minimal oversight
Understands basic project management and quality systems (e.g., Change Control, document management system)
Strong communication and teamwork skills
Solid grasp of material investigation methods
Stays informed about regulatory and quality requirements in manufacturing
Knowledgeable of material investigation principles and techniques
Preferred
Prior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshooting
Experience supporting the following: Writing portions of regulatory filings and regulatory audits
New product launches and validation of process
Global or multi-site validation programs
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