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.