The Engineer will support formulation/packaging and validation/qualification activities within operations, providing technical support for process deviations and corrective actions
Job Summary
The Engineer will support formulation/packaging and validation/qualification activities within operations, providing technical support for process deviations and corrective actions.
Responsibilities include acting as a subject matter expert, using data analytics for process improvements, authoring change controls and validation protocols, and managing technical projects.
The role requires compliance with cGMPs in an FDA-regulated environment and may involve facility support during non-routine hours and travel for factory acceptance testing.
Matching Summary
The Engineer will support formulation/packaging and validation/qualification activities within operations, providing technical support for process deviations and corrective actions.
Skills & Requirements
Must-have
Formulation and packaging support
Process deviation investigation
Corrective action implementation
Cross-functional team collaboration
cGMP compliance
Data analytics for process improvement
Nice-to-have
Lean Six Sigma methodologies
Value stream mapping
Visual management
5S implementation
Key Requirements
5+ years of related experience
Degree in Chemistry or Engineering/related field
Experience applying continuous improvement tools
Understanding of statistical analysis
Experience in pharmaceutical environment preferred