Manager Computer System Validation Engineer (csv)

Johnson & Johnson MedTech

Wilson, North Carolina, United States
**
Computerized system validation (csv)
Automation platforms including emerson deltav
Gmp manufacturing environment experience
** Johnson & Johnson MedTech is seeking a Manager Computer System Validation Engineer to lead the development and execution of the Computerized System Validation (CSV) strategy within their highly automated manufacturing facility in Wilson, North Carolina. The ideal candidate will have significant experience in biopharmaceutical or pharmaceutical GMP environments, focusing on regulatory compliance and validation of automation systems. **

Job Summary

  • The role will drive the development of strategy for Computerized System Validation aligned to site and global standards as well as to the industry best practices.
  • Ensure that automated systems are fit for intended use and follow applicable regulatory requirements and company manufacturing standards throughout the entire system life cycle.
  • Johnson & Johnson provides an inclusive work environment where each person is considered as an individual and respects the diversity and dignity of employees.

Matching Summary

Match Score: 75

** Johnson & Johnson MedTech is seeking a Manager Computer System Validation Engineer to lead the development and execution of the Computerized System Validation (CSV) strategy within their highly automated manufacturing facility in Wilson, North Carolina. The ideal candidate will have significant experience in biopharmaceutical or pharmaceutical GMP environments, focusing on regulatory compliance and validation of automation systems. **

Skills & Requirements

Must-have

  • Computerized system validation (CSV)
  • Automation platforms including Emerson DeltaV
  • GMP manufacturing environment experience
  • Change management and change control
  • Validation lifecycle documentation
  • Regulatory compliance and inspection readiness

Nice-to-have

  • Leadership and team management
  • Continuous improvement efforts
  • Cross-functional collaboration
  • Process improvements
  • Inclusive work environment
  • Data integrity implementation

Key Requirements

  • Minimum Bachelor Degree in Engineering or equivalent
  • 6+ years biopharmaceutical or pharmaceutical GMP experience
  • 2+ years GMP-regulated Execution Systems or Automation role
  • Experience supporting FDA, EMA, and global inspections
  • Supervision and management of people and resources
  • Knowledge of cGMP regulations including 21 CFR Part 11 and EU GMP Annex 11

Work Rights

Not specified

Tailored Resume

Cover Letter