The role involves providing technical support for pMDI production, including investigating and correcting process-related problems and deviations from standards
Job Summary
The role involves providing technical support for pMDI production, including investigating and correcting process-related problems and deviations from standards.
Candidates will serve as the Subject Matter Expert (SME) for overall pMDI process and operations while leading technical transfers to and from the site.
Responsibilities include ensuring GMP and AZ compliance through validation activities, cleaning strategies, and maintaining SAP/MES master data.
Matching Summary
The role involves providing technical support for pMDI production, including investigating and correcting process-related problems and deviations from standards.
Skills & Requirements
Must-have
pMDI production process support
GMP and AZ compliance standards
Technical Transfer (TT) leadership
Validation and Cleaning Validation expertise
SAP/MES master data management
Statistical Process Control (SPC)
Root Cause Analysis (RCA)
Nice-to-have
Data science and digital solutions
Lean manufacturing tools
Smart factory automation vision
Cross-functional collaboration skills
Continuous improvement mindset
Key Requirements
Experience in pharmaceutical process engineering
Knowledge of GMP and AZ regulatory standards
Proficiency in validation and qualification activities
Ability to lead technical transfer projects
Skills in data analysis and statistical process control