Csv Specialist

Johnson & Johnson

Nijmegen, Netherlands
Base: 44,700 eur to 70,840 eur annually; bonus/equ...
**
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 site, focusing on ensuring compliance with regulatory requirements in the Medical Device Sector. The ideal candidate will have experience in software validation within a regulated industry and will be responsible for assessing and overseeing the CSV program. **

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.
  • In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions.

Matching Summary

Match Score: 75

** Johnson & Johnson is seeking a Computer System Validation (CSV) Specialist for their Nijmegen site, focusing on ensuring compliance with regulatory requirements in the Medical Device Sector. The ideal candidate will have experience in software validation within a regulated industry and will be responsible for assessing and overseeing the CSV program. **

Salary

Base: 44,700 EUR to 70,840 EUR annually; Bonus/Equity: Annual bonus; Benefits: 8% holiday allowance, vacation days, parental leave, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, financial/physical/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

Nice-to-have

  • Customer Centricity
  • Data Savvy
  • Execution Focus
  • Process Improvements
  • Technologically Savvy

Key Requirements

  • Bachelor's degree or higher
  • 3-4 years of experience
  • Software validation and/or quality assurance
  • Regulated industry experience

Work Rights

Not specified

Tailored Resume

Cover Letter