Computer Systems Engineer

X4 Life Sciences; Frankfurt; Vor Ort; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A leading global pharmaceutical company is seeking a CSV Lead to support a major capital investment program at their Frankfurt site. This long-term contract requires extensive experience in leading CSV efforts across high-impact projects, managing a team, and ensuring compliance with regulatory standards.

Qualifikationen

• Extensive experience leading CSV activities on large-scale projects.
• Strong understanding of GMP compliance and regulatory expectations.
• Experience with complex automation and IT systems in a regulated environment.

Aufgaben

• Lead and manage the CSV team, ensuring timely delivery.
• Develop CSV master plans and validation strategies.
• Act as the lead engineer for review and validation of systems.

Kenntnisse

Team Leadership

GMP Compliance

Risk Management

Documentation Planning

Automation Project Management

Jobbeschreibung

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Client Growth Director at X4 Group | Leadership, Sales Growth

Location: Frankfurt, Germany – Field Based (estimated 3 days per week on site)

A leading global pharmaceutical company is seeking a CSV Lead to support a major capital investment program at their Frankfurt site. This is a long-term contract opportunity for an experienced professional to lead Computer System Validation (CSV) efforts across multiple high-impact projects.

• 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.
• 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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Consulting

• Industries

  Pharmaceutical Manufacturing

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