Engineer/Scientist 2 Material Science

Fujifilm•Holly Springs, NC

14d

About The Position

Position 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.

Requirements

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
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

Nice To Haves

Prior drug substance or manufacturing experience, including process validation, transfer and commercialization, and manufacturing support and troubleshooting
Experience supporting the following: o Writing portions of regulatory filings and regulatory audits o New product launches and validation of process o Global or multi-site validation programs

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