CSV Manager (m/f/x)

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In this exciting CSV role, you will be the main contact person for questions and issues around Computer System Validation and Process Validation. As part of their innovative medical devices team, you will contribute to developing and optimizing systems that enhance the quality and safety of medical products and services.

These tasks are waiting for you:

• Ensure compliance and maintain the validated state of all GxP-relevant computerized systems across various departments, in alignment with current regulatory requirements (e.g., FDA, EMA)
• Develop and maintain comprehensive validation documentation, including test plans, protocols, and reports
• Create and execute risk assessments, user requirement specifications (URS), and qualification/validation protocols
• Prepare and execute periodic reviews to confirm ongoing system compliance and performance
• Collaborate with and advise system owners, end-users, and project leads on Computerized System Validation (CSV) strategies and best practices
• Drive continuous process improvements within validation and system lifecycle activities
• Ensure data integrity and regulatory compliance
• Oversee (partial) project management tasks, including system administration and coordination across validation initiatives

This completes your profile:

• Studies in Computer Sciences, Business Informatics, Quality Management or a comparable field/qualification
• 3+ years of practical experience in Computer System Validation (CSV), ideally in the medical technology industry
• Experience in the validation and implementation of IT systems and software solutions
• Knowledge of regulatory requirements (e.g., GMP Annex 11, 21 CFR art 11) and strong familiarity with the GAMP5 guidelines
• Fluent German and good English skills, both written and spoken
• Independent, analytical, and structured working style with strong problem-solving skills
• Team-oriented

What the company offers you:

• Flat hierarchies with room for your own ideas
• Hybrid working environment
• Company pension plan
• Team events and different sports

About our client:

Our client is a leading German medical technology manufacturer that creates advanced medical devices. Their products are known for their reliability and innovation, and their team of experts includes engineers, scientists, and medical professionals who work together to design and develop new technologies. They are committed to improving the quality of patient care and are always looking for ways to innovate and improve their products.

Looking forward to your application!

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance and Information Technology

• Industries

  Medical Equipment Manufacturing, Biotechnology Research, and Pharmaceutical Manufacturing

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