Csv Specialist

Johnson & Johnson Innovative Medicine

Nijmegen, Netherlands
Base: 44,700 eur to 70,840 eur; bonus/equity: annu...
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Computer system validation (csv)
Gxp-relevant computerized systems
Fda 21 cfr part 11
** Johnson & Johnson is seeking a Computer System Validation (CSV) Specialist for their Nijmegen, Netherlands location. The role involves ensuring compliance with regulatory requirements and overseeing the CSV program for the site, focusing on validation documentation and risk assessment. **

Job Summary

  • The Computer System Validation (CSV) Specialist is responsible for assessing systems at the Nijmegen site to ensure compliance with all relevant procedures and regulatory requirements.
  • Develop, and review lifecycle documents, including validation plans, system requirements, design specifications, protocols, and reports for GxP-relevant computerized systems.
  • The anticipated base pay range for this position is 44,700 EUR to 70,840 EUR on an annual basis and includes 8% holiday allowance.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Computer System Validation (CSV) Specialist for their Nijmegen, Netherlands location. The role involves ensuring compliance with regulatory requirements and overseeing the CSV program for the site, focusing on validation documentation and risk assessment. **

Salary

Base: 44,700 EUR to 70,840 EUR; Bonus/Equity: annual bonus; Benefits: 8% holiday allowance, vacation days, parental leave, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, financial, physical and mental health programs, insurance plans

Skills & Requirements

Must-have

  • Computer System Validation (CSV)
  • GxP-relevant computerized systems
  • FDA 21 CFR Part 11
  • EU Annex 11
  • GAMP 5
  • Data Integrity (DI)
  • Good Manufacturing Practices (GMP)

Nice-to-have

  • Customer Centricity
  • Execution Focus
  • Process Improvements
  • Quality Systems Documentation
  • Technologically Savvy

Key Requirements

  • Bachelor's degree or higher in Engineering, Computer Science, Life Sciences or related field
  • Minimum of 3-4 years of experience in software validation
  • Ability to work with cross-functional teams
  • Ability to work on own initiative and as a team player

Work Rights

Not specified

Tailored Resume

Cover Letter