Base: 44,700 eur to 70,840 eur; bonus/equity: annu...
Hybrid (assumed based on industry practices and not explicitly stated)
Computer system validation (csv)
Gxp-relevant computerized systems
Risk-based approach
Johnson & Johnson is seeking a Computer System Validation (CSV) Specialist for its Nijmegen, Netherlands location, responsible for ensuring compliance with relevant procedures and regulatory requirements in the Medical Device Sector. The role involves technical leadership in validation activities, documentation development, and collaboration with cross-functional teams
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 vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, and programs for financial, physical and mental health.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Computer System Validation (CSV) Specialist for its Nijmegen, Netherlands location, responsible for ensuring compliance with relevant procedures and regulatory requirements in the Medical Device Sector. The role involves technical leadership in validation activities, documentation development, and collaboration with cross-functional teams.
Salary
Base: 44,700 EUR to 70,840 EUR; Bonus/Equity: annual bonus with set target; 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
risk-based approach
FDA 21 CFR Part 11
EU Annex 11
GAMP 5
Nice-to-have
Customer Centricity
Data Savvy
Execution Focus
Lean Supply Chain Management
Process Improvements
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
Ability to work with cross-functional teams
Ability to work on own initiative and as a team player