Computer System Validation (CSV) Specialist (m/f/d)

Computer System Validation (CSV) Specialist (m/fh3>

Computer System ValidationCSV) Specialist (m/f/d) – German Speaker (Medical Device/Pharma)

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 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)

Location:

Baden-Württemberg, Germany (on‑site 5 days/week)

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