Johnson & Johnson is seeking a Manager Computer System Validation Engineer to lead the development and execution of Computerized System Validation (CSV) strategies for their biopharmaceutical manufacturing facility in Wilson, North Carolina. The ideal candidate will possess extensive experience in CSV activities within a GMP-regulated environment and demonstrate strong leadership and technical skills
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 to lead the development and execution of Computerized System Validation (CSV) strategies for their biopharmaceutical manufacturing facility in Wilson, North Carolina. The ideal candidate will possess extensive experience in CSV activities within a GMP-regulated environment and demonstrate strong leadership and technical skills.
Skills & Requirements
Must-have
Computerized System Validation (CSV)
cGMP regulations
21 CFR Part 11
EU GMP Annex 11
Data Integrity (ALCOA+)
GAMP 5 methodologies
Emerson DeltaV
OSIsoft PI
Siemens PLCs
Nice-to-have
Inclusive leadership
Developing others
Innovation
Process improvements
Lean supply chain management
Quality assurance (QA)
Key Requirements
Minimum 6+ years of experience in GMP manufacturing with CSV
Minimum 2 years of experience in GMP Execution Systems, Automation, or IT
Experience in supervision/management of people and resources