CSV Lead (m/f/x)
Negotiable
Hamburg

As CSV Manager (m/f/x), you are responsible for managing the IT Validation capability within the IT Assurance function. You are part of the Global IT Organization.


These tasks are waiting for you:

  • Collaborate closely with all Global IT departments to ensure that validated environments comply with GMP and other regulatory standards relevant to MedTech
  • Oversee, execute, and manage all computer software validation operations within the Global IT organization
  • Ensure the preparation, review, and approval of validation documentation, including CSV/CSA risk assessments, change control forms, validation plans, data migration strategies, IQ, OQ, PQ/UAT test protocols and reports
  • Conduct an initial Quality Gate assessment when new applications or software are introduced to determine if validation is necessary
  • Offer guidance to Global IT projects and programs regarding validation processes
  • Conduct audits to verify that governance and change management protocols are properly implemented


This completes your profile:

  • Bachelor's degree in Life Sciences, Computer Science, Business, or a related field (or equivalent relevant experience preferred)
  • 3+ years of experience in computer system validation, ideally within the Life Science industry
  • Familiarity with quality risk management and GxP regulatory frameworks
  • Background in project management
  • Proven track record working in a global, multi-divisional technology setting
  • Strong knowledge and practical application of FDA regulations and other compliance standards
  • Fluent English skills and good German skills

This is what the position offers you:

  • Flexible working hours
  • A comprehensive company pension scheme
  • Regular training courses
  • Free parking or a ticket for the Hamburg public transport network
  • Health care and medical check-ups
  • A staff restaurant and subsidized lunches
  • 30 days of holiday time each year

Information about our client:

The company is a global company focusing on minimally invasive therapies for Medical Devices and Life Sciences with an IT team that is globally connected and drives innovation. They encourage a collaborative environment and are looking for curious personalities to improve people's lives together.

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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.