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FUJIFILM Cellular Dynamics, Inc · 2 months ago

QA Engineer, DSM (Project QA)

US-NC-Holly Springs

Full-time

Onsite

Mid, Senior Level

3+ years exp

FUJIFILM Cellular Dynamics, Inc is a company focused on biotechnologies, and they are seeking a QA Engineer for Drug Substance Manufacturing (DSM). This role is responsible for ensuring quality oversight of DSM project processes and maintaining validation throughout the lifecycle of manufacturing systems.

BiotechnologyHealth CareManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

Performs an SME role within the QA team for the development of documents, processes, and procedures for the DSM program

Assesses the impact of system and process modifications and maintains oversight of change management processes to ensure Manufacturing Systems are first validated and then maintained in a validated state through startup and into commercial operation

Provides oversight and approval of system and process lifecycle documentation, including risk and impact assessments, product, process and equipment specifications, functional specifications, traceability matrices, qualification protocols, validation plans, and validation summary reports

Generates, reviews, and approves QA procedures for the validation approach and lifecycle documents for Manufacturing Systems

Generates, reviews, and approves QA documentation, procedures, and processes for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility

Ensures project and operational quality objectives are met within desired timelines

Collaborates and aligns with other FUJIFILM Biotechnologies sites to streamline processes and maximize efficiency

Participates in optimization or improvement initiatives and support regulatory agency and third‐party inspections

Performs other duties as assigned

Qualification

GMP experienceValidationQuality oversightCQVCGMP manufacturingFDA regulationsASTM E2500SmartsheetsTrackWiseVeevaKneat softwareClean in Place (CIP)Steam in Place (SIP)

Required

BS/BA in Life Sciences or Engineering or equivalent with 5+ years of applicable GMP industry experience OR

MS in Life Sciences or Engineering and 3+ years of applicable experience OR

PhD in Life Sciences or Engineering and with 1+ years of applicable experience

3+ years of experience working in a GMP regulated environment

Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility

Experience in Commissioning, Qualification, and Validation (CQV), Current Good Manufacturing Practices (cGMP) manufacturing operations and/or Quality oversight, in a Food and Drug Administration (FDA) regulated facility

Preferred

Experience and working knowledge of ASTM E2500, Smartsheets, TrackWise, Veeva, and/or Kneat validation software

Experience with Greenfield or startup projects or initiatives

Familiarity/understanding of qualification / validation of production equipment, hygienic utilities, quality systems, automation, manufacturing & IT systems, clean rooms, classified spaces, controlled temperature units (CTUs), Cleaning verification and validation, Clean in Place (CIP) / Steam in Place (SIP), and associated testing methodologies

Company

FUJIFILM Cellular Dynamics, Inc

Fujifilm Cellular Dynamics, Inc. develops and manufactures biologically relevant human cells derived from induced pluripotent stem (iPS) cells.

Founded in 2004

Madison, Wisconsin, USA

51-200 employees

https://www.fujifilmcdi.com

H1B Sponsorship

FUJIFILM Cellular Dynamics, Inc 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

2023 (4)

2021 (1)

2020 (3)