Description: The Associate Process 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.