Sr Engineer - Validation Process

Descripción del Empleo:
Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
Requisitos:
Bachelor’s degree in Engineering and 5 years of Engineering experience.
Experience working of pharmaceutical/biotech processes
Experience with validation processes
Experience working with documentation in a highly regulated environment
Ability to operate specialized laboratory equipment and computers as appropriate.
Ability to interpret and apply GLPs and GMPs.
Ability to apply engineering science to production.
Able to develop solutions to routine technical problems of limited scope
Knowledge or experience in Validation Protocol Writing
Specialized equipment/process expertise
In-depth knowledge of validation processes and requirements as applied to new equipment installations
Knowledge in vision systems
Knowledge in equipment controls (PLC, HMI, Servodrives, etc)
Knowledge in Lean Manufacturing, Six Sigma or Quality by Design