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    CSV Specialist - Muskegon, United States - Piper Companies

    Piper Companies
    Piper Companies Muskegon, United States

    3 days ago

    Default job background
    Description

    Piper Health & Sciences is seeking an experienced
    Computer Systems Validation (CSV) Specialist to join a rapidly growing life sciences organization in the
    Muskegon, MI area.


    Responsibilities for the CSV Specialist include:

    • Collaborate with QA leadership in order to develop and implement new, efficient CSV programs for a GLP-regulated environment.
    • Conduct internal audits/assessments to identify computerized system validation needs, or host and assist in external audits, as needed.
    • Assist QA with auditing vendors of cGMP related software and hardware and evaluating vendor validation protocols.
    • Assist with sitewide computer validation projects and perform periodic review of all validated systems.
    • Develop SOPs/protocols for software and computer validations.

    Qualifications for the CSV Specialist include:

    • 5+ years of experience in Computer Systems Validations.
    • Bachelor's degree in relevant field is required.
    • Knowledge of GxP, GLPs, 21 CFR Part 11, and other federal IT regulations.
    • Understanding of laboratory operations, data collection, and workflows.

    Compensation for the CSV Specialist includes:

    Salary Range:
    approximately $85,000 - $100,000 annually, commensurate with experience

    Full Benefits:
    Medical, Dental, Vision, 401k, PTO, Paid Holidays

    CSV Specialist, csv engineer, computer systems validation, computer validation specialist, gxp, glp, good laboratory practices, life sciences, cro, clinical research, preclinical research, software validation, master validation schedule, vendor qualification, qa, quality assurance, site validation, laboratory, hybrid

    #LI-CP1

    #LI-ONSITE
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