Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management
Job Summary
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management.
Develop, interpret and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
Matching Summary
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management.
Skills & Requirements
Must-have
process validation and control
risk management
investigation and correction of failures
develop control plans
process monitoring and control methods
statistical analysis and interpretation
sampling plans
manufacturing equipment and processes
Nice-to-have
stakeholder analysis
measurement systems capabilities
destructive and non-destructive tests
design controls
new product introduction support
hands on troubleshooting
decision making based on standards
Key Requirements
2-4 years related experience
Bachelor’s Degree
FDA and European regulatory environment experience preferred