Csv Specialist

J&J FAMILY OF COMPANIES

Nijmegen, Netherlands
Base: 44,700 eur to 70,840 eur; bonus/equity: annu...
Not specified (assumed to be hybrid based on industry standards)
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 site. The role focuses on ensuring compliance with regulatory requirements in the Medical Device Sector, with responsibilities including validation documentation, risk assessments, and providing technical leadership

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.
  • Responsibilities include developing and reviewing lifecycle documents, executing validation protocols, and conducting risk assessments to ensure compliance with applicable regulations.
  • The anticipated base pay range is 44,700 EUR to 70,840 EUR annually, with additional benefits including an annual bonus, vacation days, parental leave, and various wellness programs.

Matching Summary

Match Score: 85

Johnson & Johnson is seeking a Computer System Validation (CSV) Specialist for their Nijmegen, Netherlands site. The role focuses on ensuring compliance with regulatory requirements in the Medical Device Sector, with responsibilities including validation documentation, risk assessments, and providing technical leadership.

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
  • Technologically Savvy
  • Quality Systems Documentation

Key Requirements

  • Bachelor's degree or higher
  • 3-4 years of experience in software validation
  • Experience in regulated industry (pharma, biotech, medical devices)
  • 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