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    Senior Validation Engineer - New York, United States - BioPhase

    BioPhase
    BioPhase New York, United States

    Found in: Appcast US C2 - 1 week ago

    Default job background
    Description
    *US Citizens or Greencard Holders only
    • Work Schedule:
    Onsite - M-F

    Salary:
    $60-70/hr

    Duration:

    4 months


    Primary Responsibilities:
    Support the Quality Engineering group with documentation and validation needs.
    Draft URS documents, design specifications, testing protocols, and final reports.
    Perform hands on validation execution for automation implementation project.
    Draft protocol discrepancy reports and support resolution.
    Review and approval of validation documents.
    Utilize specified document review / approval process to submit specifications, forms, and protocols for approval.
    Establish schedules with vendors and internal departments as needed.
    Liaise between support organizations, Microbiology, Quality, Engineering, Validation, Regulatory Affairs, Process Development, etc.
    Attend Project meetings and relay project status as required.

    Write / review equipment and computer system documentation – specifications, C&Q test protocols, final reports, and route for approval as required.

    Scheduling equipment and computer systems validation execution and documentation activities in accordance with project priorities.
    Escalate issues to leadership as needed.
    May perform project management and other tasks, as needed.


    Qualifications:

    • Bachelor's Degree and 5+ years' experience in Quality and/or Manufacturing within pharmaceutical, biotechnology, biologics, and/or cell therapy operations

    Knowledgeable in various areas of equipment and computerized systems with strong understanding of data integrity, life cycle approach, and change control management.

    Self-motivated / disciplined.
    Experience with automation equipment, bioreactors, temperature-controlled units, and cell processing systems preferred.
    Strong interpersonal communications skills with excellent technical writing abilities.
    Demonstrated application of engineering principles on projects.
    Possess in-depth knowledge of cGMP and regulations related to biotech / pharmaceutical qualifications.
    Proficient in Microsoft Office tools (Power point, MS Project, Excel, and Word).
    Able to work collaboratively and cross-functionally with other departments and vendors
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