Computer System Validation
vor 6 Stunden
Computer System Validation (CSV) Specialist (m/f/d) – German Speaker (Medical Device/Pharma)
Location:
Baden-Württemberg, Germany (On-site, 5 days/week)
About the Role:
We are seeking a skilled CSV (Computer System Validation) Specialist to support a major manufacturing site in the Baden-Württemberg region of Germany. If you have hands-on experience validating laboratory or quality systems in regulated environments, and are looking for a challenging, visible role in the medical device or pharmaceutical sector, we would like to hear from you
Key Responsibilities:
- Lead and manage CSV activities for laboratory systems in accordance with industry regulations and internal standards
- Develop and execute validation strategies with autonomy and confidence
- Prepare, maintain, and present critical validation documentation in both German and English
- Serve as a subject matter expert and advisor for the local quality and compliance team
- Support audits and regulatory inspections, clearly articulating validation approaches and findings
Requirements:
- German language: Fluent in speaking, writing, and reading
- CSV experience: Minimum 2–3 years' hands-on experience in Computer System Validation, ideally with laboratory systems
- Industry experience: Proven track record in Medical Devices and/or Pharmaceuticals
- Autonomy: Demonstrated ability to work independently, challenge assumptions, and set strategic validation direction
- Location: Must be based in or willing to relocate to Baden-Württemberg, with a requirement to be on-site 5 days/week (home office options may be discussed)
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