CSV Manager

vor 2 Monaten

Mainz, Deutschland SciPro Vollzeit

(Sr.) CSV Manager (m/f/x) | Mainz Area | Pharma

Join a trusted and innovative pharmaceutical company as a key expert (m/f/x) in computer system validation. Your expertise will guide essential validation processes, and you’ll engage in exciting projects that make a real difference in advancing healthcare solutions.


These tasks are waiting for you:

  • Planning, coordination, and execution of computer system validation in compliance with current regulations
  • Ensuring regulatory compliance throughout all stages of computer system validation
  • Conducting risk management within the scope of computer system validation (CSV)
  • Managing all documentation generated during validation projects
  • Preparing final validation reports and ensuring data and system security
  • Planning, supervising, and monitoring validation, qualification, and calibration activities
  • Coordinating and overseeing deviation management
  • Preparing and reviewing GMP-related documentation
  • Support in external audits


This completes your profile:

  • Degree in Computer Sciences or comparable qualifications with relevant work experience
  • 4+ years of professional experience in a CSV role, preferably in the pharmaceutical industry or medical device industry
  • In-depth knowledge of regulatory requirements (GxP, CFR 21 Part 11/EU GMP Annex 11, GAMP5)
  • Excellent communication skills and a methodical, quality-focused approach to work
  • Fluency in both German and English


Benefits:

  • Flexible working hours with 30 days of holiday
  • Personal and professional development
  • Health offers such as JobRad, Wellpass, and sports groups
  • Collaborative and appreciative work environment, with flat hierarchies


Information about our client:

Our client is a well-established company in the pharmaceutical industry, offering end-to-end services across drug development, manufacturing, and supply chain management. Known for quality and innovation, the company provides a collaborative work environment focused on efficiency and quick decision-making, supported by a close-knit, professional culture.