Not specified (potentially supportive of onsite or hybrid arrangements based on the nature of the role).
Computerized system validation (csv)
Cgmp regulations
Data integrity (alcoa+)
Johnson & Johnson is seeking a Manager Computer System Validation Engineer for their Wilson, North Carolina location. The role focuses on developing and executing strategies for computerized system validation in a biopharmaceutical setting, requiring substantial experience in regulatory compliance and automation
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 (e.g. cG(a)MP) and company manufacturing standards throughout the entire system life cycle.
Establish effective working relationships with Quality, IT, Lab Systems, Procurement, and others by developing new partnerships to identify continuous improvement opportunities of site validation practices.
Matching Summary
Match Score: 85
Johnson & Johnson is seeking a Manager Computer System Validation Engineer for their Wilson, North Carolina location. The role focuses on developing and executing strategies for computerized system validation in a biopharmaceutical setting, requiring substantial experience in regulatory compliance and automation.
Skills & Requirements
Must-have
Computerized System Validation (CSV)
cGMP regulations
Data Integrity (ALCOA+)
Execution Systems (ES)
ISA S95 & S88 standards
Nice-to-have
Inclusive Leadership
Developing Others
Innovation
Process Improvements
Lean Supply Chain Management
Key Requirements
Minimum 6+ years of experience in GMP manufacturing
Minimum 2 years of experience in GMP-regulated Execution Systems, Automation, or IT