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CSV Lead

Katalyst Healthcares & Life Sciences
  • Piscataway, NJ
  • Instant Apply
30+ days ago

Job Description

Roles & Responsibilities:
  • Lead and manage Computer System Validation (CSV) activities across regulated Life Sciences projects.
  • Develop and review validation plans, protocols, test scripts, reports, and validation documentation.
  • Lead validation lifecycle activities including URS, FS/DS, IQ, OQ, PQ, UAT, and RTM.
  • Perform risk assessments and ensure systems are validated in compliance with GxP requirements.
  • Support validation of GxP computerized systems, laboratory systems, manufacturing systems, and enterprise applications.
  • Manage deviations, CAPA, change controls, and validation-related investigations.
  • Provide technical leadership and coordinate with QA, IT, Engineering, Manufacturing, and Business teams.
  • Ensure compliance with FDA regulations, 21 CFR Part 11, GAMP5, and data integrity requirements.
  • Support audits, inspections, and inspection-readiness activities.
  • Manage project timelines, deliverables, and validation documentation.
Required Qualifications:
  • 10+ years of experience in CSV / Computer System Validation within Pharma, Biotech, Medical Device, or Life Sciences.
  • Strong knowledge of GxP validation lifecycle and risk-based validation approaches.
  • Hands-on experience with URS, FS/DS, IQ/OQ/PQ, UAT, RTM, and validation reports.
  • Strong knowledge of 21 CFR Part 11, GAMP5, FDA, and data integrity requirements.
  • Experience with deviations, CAPA, change control, and risk assessments.
  • Strong technical documentation and project leadership skills.
  • Experience working with cross-functional teams in regulated environments
  • Experience with laboratory systems such as LIMS, CDS, ELN, or SDMS.
  • Experience with manufacturing systems, MES, ERP, or automation-related systems.
  • Experience with systems such as LabWare, Empower, TrackWise, Veeva, or SAP.
  • Experience with data integrity assessments and audit/inspection support.
  • Experience leading CSV teams and managing multiple validation projects.

Numbers & Facts

LocationPiscataway, NJ

Skills

  • Acceptance Testingunmatched
  • Automationunmatched
  • Biologyunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Code of Federal Regulationsunmatched
  • Computer Skillsunmatched
  • Computer Systemsunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Data Qualityunmatched
  • ERP (Enterprise Resource Planning)unmatched
  • Enterprise Applicationsunmatched
  • FDA (Food and Drug Administration)unmatched
  • FDA Requirementsunmatched
  • GxPunmatched
  • Information Technology & Information Systemsunmatched
  • Laboratoryunmatched
  • Laboratory Information Management System (LIMS)unmatched
  • Laboratory Systemsunmatched
  • Labwareunmatched
  • Leadershipunmatched
  • Maintain Complianceunmatched
  • Manufacturingunmatched
  • Manufacturing Systemsunmatched
  • Medical Equipmentunmatched
  • Multitaskingunmatched
  • Process Validationunmatched
  • Project/Program Managementunmatched
  • Quality Assuranceunmatched
  • Regulatory Complianceunmatched
  • Riskunmatched
  • Risk Analysisunmatched
  • Risk Managementunmatched
  • SAPunmatched
  • Scientific Data Management System (SDMS)unmatched
  • System Validationunmatched
  • Systems Administration/Managementunmatched
  • Team Lead/Managerunmatched
  • Technical Leadershipunmatched
  • Technical Writingunmatched
  • Test Scriptsunmatched
  • Time Managementunmatched
  • Validation Documentationunmatched
  • Validation Planunmatched

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