CSV Germany

X4 Group Ltd

  • Hesse, Moselle
  • CDI
  • Temps-plein
  • Il y a 1 mois
  • Postuler facilement
Position: CSV LeadLocation: Hesse, GermanyContract Length: 12 MonthsA leading global pharmaceutical company is seeking a CSV Lead to support a major capital investment program. This is a long-term contract opportunity for an experienced professional to lead Computer System Validation (CSV) efforts across multiple high-impact projects.CSV Lead - Key Responsibilities:
  • Team Leadership: Lead and manage the CSV team, ensuring timely delivery of all validation activities.
  • Documentation & Planning: Develop CSV master plans, project-specific validation strategies, and all supporting documentation.
  • System Oversight: Act as the lead engineer for review and validation of PAS (existing and new), BMS, EMS, Data Historian (OSI Pi), and equipment PLC systems.
  • Scope Definition: Identify the full scope of CSV and qualification efforts for both GMP and non-GMP systems.
  • Execution Support: Support automation teams in field execution, report writing, and lifecycle documentation.
  • Change Control: Lead and coordinate Automation Project Change Control (APCC) processes.
  • Vendor Coordination: Manage all CSV vendors through FAT, SAT, and IOQ phases.
  • Meetings & Reporting: Run weekly CSV meetings and report progress to the CQV Project Manager.
  • Risk Management: Participate in risk assessments including FMEA, PCL, and CIL sessions.
  • Template Development: Generate and maintain all automation/CSV project templates.
CSV Lead - Requirements:
  • Extensive experience leading CSV activities on large-scale pharmaceutical or biopharmaceutical projects.
  • Proven track record of delivering projects using a verification/leveraging approach to CSV.
  • Strong understanding of GMP compliance and regulatory expectations.
  • Experience with complex automation and IT systems in a regulated environment.
If you are an experienced CSV professional ready to take on a leadership role in a dynamic project environment, apply to Lauren Park at X4 Group or connect with Lauren to stay updated on X4 Group's latest vacancies.

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