Computerized Systems Validation (csv) Specialist/engineer/analyst

Ardena

Oss, Netherlands
Competitive salary; tailor-made benefits pyckage i...
On-site
Gxp compliance and validation strategy
21 cfr part 11 and annex 11 regulations
Data integrity assurance and capa management
Ardena is seeking a Computerized Systems Validation (CSV) Specialist/Engineer/Analyst to validate GxP-compliant computerized systems within its corporate CSV team in Oss, Netherlands. The role requires a strong background in health and life sciences, with at least five years of experience and familiarity with GxP guidelines. The position offers competitive salary, flexible working hours, and opportunities for professional growth in a dynamic international environment

Job Summary

  • You will be responsible for validating all GxP-compliant computerized systems within a global environment.
  • The role requires drawing up validation project plans and documents according to international GxP guidelines while ensuring data integrity.
  • Ardena offers a competitive salary, flexible working hours, and access to an internal learning platform for professional development.

Matching Summary

Match Score: 85

Ardena is seeking a Computerized Systems Validation (CSV) Specialist/Engineer/Analyst to validate GxP-compliant computerized systems within its corporate CSV team in Oss, Netherlands. The role requires a strong background in health and life sciences, with at least five years of experience and familiarity with GxP guidelines. The position offers competitive salary, flexible working hours, and opportunities for professional growth in a dynamic international environment.

Salary

Competitive salary; Tailor-made benefits package including insurance and allowances; Not specified

Skills & Requirements

Must-have

  • GxP compliance and validation strategy
  • 21 CFR Part 11 and Annex 11 regulations
  • Data integrity assurance and CAPA management
  • Risk-based validation documentation
  • QA, IT, and cross-functional collaboration

Nice-to-have

  • Interest in Artificial Intelligence (AI)
  • Dutch and Spanish language skills
  • Flexible problem-solving mindset
  • Willingness to travel 20% of the time
  • Experience with LIMS and CDS systems

Key Requirements

  • Bachelor's degree in scientific direction or equivalent experience
  • At least 5 years of experience in Health & Life sciences industry
  • Eligibility to work in the European Union

Work Rights

Must be eligible to work in the EU

Tailored Resume

Cover Letter