Computer System Validation Specialist (m/f/x)
Negotiable
Technical Operations
Cologne, Nordrhein-Westfalen
Permanent
Hybrid

CSV Specialist (m/f/x) | Köln/Bonn area | Pharmaceuticals

As a CSV Specialist (m/f/x) for this global pharmaceutical company, you will be responsible for the validation of computer systems within the engineering department. You will be part of a collaborative, exciting work environment and implement your expertise.

These tasks are waiting for you:

  • Ensuring the validated state of all GxP-relevant computerized systems in different areas in accordance with GMP regulations
  • Validation of computerized systems for new acquisitions and existing installations
  • Project management for computer system-related topics in projects
  • Recording and management of validation-relevant computerized systems
  • Creation and review of validation documentation and SOPs in the field of CSV
  • Conducting risk analysis and change management
  • Technical collaboration in the development, optimization, and implementation of processes and projects
  • Cooperation with interdisciplinary teams to ensure system integrity

This completes your profile:

  • Completed degree in Computer Science, Business Informatics, or a comparable technical field
  • Several years of practical experience in Computer System Validation (CSV), ideally in the chemical industry or other regulated sectors
  • Experience in the validation and implementation of complex IT systems and software solutions
  • Knowledge of regulatory requirements (e.g., GMP) and strong familiarity with the GAMP5 guidelines
  • Excellent knowledge of IT architecture and relevant technologies
  • Fluent German and good English skills, both written and spoken
  • Independent, analytical, and structured working style with strong problem-solving skills

This is what the position offers:

  • Interesting tasks with great potential for growth
  • Flexible working hours in a 37,5h work week with 30 days holiday
  • Hybrid working model
  • Other benefits such as bike leasing, group accident insurance, affordable meals in the cafeteria, free employee parking

Information about our client:

Our client is a global pharmaceutical company dedicated to providing access to high-quality, affordable medicines. The company focuses on improving global healthcare by ensuring the availability of essential treatments for cardiovascular diseases, infectious diseases, oncology, and more.

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We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference. We are a trusted partner for every step from Discovery through to Development. So, no matter where you are in your journey, we're here to help you make a difference.