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Validation Specialist (m/f/d) CSV - Remote

Posted 33 weeks ago
All others
Full Time
Worldwide

Overview

As a Validation Specialist (m/f/d) in computerized system validation (CSV), you will make a significant contribution to our business success.

In Short

  • Manage and lead projects in CSV, IT system validation, and general qualification in the pharmaceutical industry.
  • Create qualification and validation documents, including protocols and final reports.
  • Conduct and document alarm and function tests, and create GMP documents.
  • Document and moderate risk analyses and guide assigned personnel in customer projects.
  • Present projects internally and externally, and assist in acquisition and budget management.
  • Advise and support clients in CSV-related tasks.

Requirements

  • Completed degree in engineering or natural sciences or a comparable field.
  • At least 2 years of experience in the pharmaceutical industry in CSV and IT validation.
  • Profound knowledge of GMP requirements and EU-GMP guidelines.
  • Fluent in English and very good German (C1 or better).
  • Strong team player with excellent communication skills.
  • Independent, reliable, and structured working style.

Benefits

  • Flexibility of a small company with the stability of a large parent company.
  • Competitive salary with an extraordinary bonus model.
  • Interesting tasks in a technologically exciting environment.
  • Opportunities for personal and professional development.
  • A variety of attractive working conditions.
SYNTEGON logo

SYNTEGON

SYNTEGON, through its subsidiary Valicare GmbH based in Frankfurt am Main, has been providing a comprehensive range of services for the GMP environment for over 20 years, particularly for manufacturers of advanced therapy medicinal products (ATMPs). The company specializes in GMP and ISO compliance, quality management consulting, and risk-based qualification of equipment and process validation. With a focus on multidisciplinary teamwork, SYNTEGON adheres to the latest technological standards and international regulations, including FDA and GMP guidelines. The company collaborates with leading firms in the industry, offering a dynamic work environment that values expertise and innovation.

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