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Computer System Validation
Computer System ValidationAxelon Services Corporation • Davie, FL
Computer System Validation

Computer System Validation

Axelon Services Corporation • Davie, FL
1 day ago
Job type
  • Full-time
Job description

Job Title : Computer System Validation (CSV)

Location : Orange Drive, Davie, FL

Duration : Contract : months with possible extension

  • Shift : Monday to Friday am – 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 , CFR Part , 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 (, 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 : - years experience in pharmaceutical or regulated manufacturing; out of which years in quality organization years hands-on CSV experience reviewing and approving validation documentation. Direct experience supporting manufacturing or utilities systems (not just lab systems).
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    Computer System Validation • Davie, FL