Engineer/Scientist 2 Material Science

Overview The Engineer or Scientist 2, Material Science supports the design of new single-use consumables in conjunction with our manufacturing teams. This role assists the leachable and extractables program, that includes facilitation of testing based on products evaluated. This role also supports manufacturing investigations involving material science (e.g., raw material variability and concerns, consumable issues and particle sources). The role writes investigation reports and leachable and extractable reports. Job Description What You’ll DoSupports the team with the introduction of new raw materials, and associated document requirementsAssesses vendor change notifications, and provides input on raw materials related mattersSupports change requests for introduction, modification, and discontinuation of raw materialsProvides 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 neededDelivers documentation for internal and external use, such as comprehensive written protocols and reports, summarizing investigations and impact assessments, studies and projectsSupports 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 projectsSupports generation of sampling plans for process validation reports (PVRs) and investigationsCollaborates 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 costAssists in solutions in selecting methods, evaluating, adapting of complex techniques to obtaining results consistent with departmental objectivesOther duties, as assignedKnowledge and SkillsBuilds connections with key contacts within the department and outside specialtyCommunicates effectively within the teamEngages in important conversations with cross-functional team membersDevelops basic hypotheses for projectsPossesses fundamental project management skills. Effectively communicates information to othersThinks critically and self-directed with minimal oversightUnderstands basic project management and quality systems (e.g., Change Control, document management system)Strong communication and teamwork skillsSolid grasp of material investigation methods Stays informed about regulatory and quality requirements in manufacturingKnowledgeable of material investigation principles and techniquesBasic RequirementsBachelor’s degree in Engineering, Life Science or Chemical Engineering with 2 years of applicable industry experience; ORMaster’s degree in Engineering, Life Science or Chemical Engineering with no relevant experienceExperience working in a Good Manufacturing Practices (GMP) environmentPreferred RequirementsPrior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshootingExperience supporting the following:o Writing portions of regulatory filings and regulatory auditso New product launches and validation of processo Global or multi-site validation programsWORKING CONDITIONS & PHYSICAL REQUIREMENTSAbility to discern audible cues.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. Options Sorry the Share function is not working properly at this moment. Please refresh the page and try again later. Share on your newsfeed Software Powered by iCIMS