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FUJIFILM Biotechnologies · 2 weeks ago

QA Engineer, DSM (Project QA)

Holly Springs, NC

Full-time

Onsite

Senior Level

5+ years exp

FUJIFILM Biotechnologies is seeking a QA Engineer for Drug Substance Manufacturing (DSM) to provide quality oversight of DSM project processes. This role involves ensuring validation program execution and maintaining systems in a validated state while collaborating with other sites to streamline processes and support operational quality objectives.

BiotechnologyHealth CareManufacturing

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 experienceValidation experienceQuality oversightCQV experienceCGMP manufacturingFDA regulationsASTM E2500SmartsheetsTrackWiseVeevaKneat softwareGreenfield projectsProduction equipment validationClean 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 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

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Trends of Total Sponsorships

2021 (1)