Computer Systems Engineer

X4 Life Sciences Frankfurt

Stellenbeschreibung:

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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.