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FUJIFILM Biotechnologies · 23 hours ago

Engineer/Scientist 2 Material Science

Holly Springs, NC

Full-time

Onsite

Entry, Mid Level

2+ years exp

FUJIFILM Biotechnologies is seeking an Engineer or Scientist 2 in Material Science to support the design of new single-use consumables alongside manufacturing teams. The role involves managing material science investigations, writing reports, and collaborating with various departments to ensure quality and compliance in manufacturing processes.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

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

Material investigation methodsManufacturing Practices (GMP)Project managementRegulatory requirementsProcess validationCommunication skillsTeamwork skillsCritical thinking

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 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

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)