Job Summary

The Validation Engineer reports to the Technical Lead or head of Technical Services. Executes Process/Cleaning Validation/Study assignments as per directives. Creates protocols, data collection and analysis and prepare reports under supervision.

Essential Functions

Prepare validation protocols & reports for manufacturing process and cleaning process qualification; data analysis and prepare reports; execute manufacturing process and cleaning process qualification/validation/study Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements Prepare and review manufacturing batch record and other engineering qualification documents as required Coordinate/oversee the development of new processes or troubleshoot existing ones Review Annual Product Review reports and plot trend analysis & APR reports Assist in deviation/investigations to identify root causes and define corrective and/or preventative actions (CAPA) Assist in various audits

Additional Responsibilities

Performs other functions as required or assigned. Complies with all company policies and standards. Initiation of Change Controls and Planned Deviations when required Reviews manufacturing/ Packaging batch records and Engineering qualification documents Performs other functions as required or assigned. Complies with all company policies and standards.