Computer System Validation - Fort Lauderdale - Axelon Services Corporation

    Axelon Services Corporation
    Axelon Services Corporation Fort Lauderdale

    1 day ago

    Description


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    Job Title: Computer System Validation (CSV)
    Location: 4955 Orange Drive, Davie, FL
    Duration: Contract: 6 months with possible extension
    • Shift: Monday to Friday 8am – 5 pm
    Key Responsibilities:
    • Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports).
    • Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA) principles.
    • Evaluate system changes through change control, assessing GxP impact and validation requirements.
    • Support periodic reviews and re-validation activities for existing systems.
    Digital Systems & Platforms:
    • Act as Quality reviewer/approver for systems including:
      • MES / EBR platforms (e.g., Werum Client-X or similar)
      • Historians (OSIsoft PI or equivalent)
      • Advanced analytics tools (Seeq, used for GxP trending)
      • Empower and other lab systems
    • Review configurations related to data acquisition, time stamping, audit trails, access control, and electronic records/signatures.
    • Ensure proper segregation between GxP vs non-GxP analytics use cases.
    Data Integrity & Compliance:
    • Assess and approve data flows, interfaces, and integrations between systems.
    • Support regulatory inspections (FDA, EMA) and internal audits related to computerized systems.
    Cross-Functional Collaboration:
    • Partner with Engineering, Automation, MS&T, IT, and Operations to:
      • Enable faster project execution with compliant validation strategies
      • Avoid over-validation while maintaining inspection readiness
    • Provide Quality input during project design, FAT/SAT, and commissioning phases.
    Required Qualifications:
    • Education:
      • Master's degree in Engineering, Computer Science, Life Sciences, or related field.
    • Experience:
      • 3-5 years experience in pharmaceutical or regulated manufacturing; out of which 2 years in quality organization
      • 3 years hands-on CSV experience reviewing and approving validation documentation. xhuatnn
      • Direct experience supporting manufacturing or utilities systems (not just lab systems).

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