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.

Education:

• Bachelors Degree (BA/BS) Pharmaceutical/Chemical Engineering - Required


• Master Degree (MS/MA) Pharmaceutical/Chemical Engineering - Preferred

Experience:

• 1 year or more in Pharmaceutical/Manufacturing Industry

Skills:

• Excellent verbal and written communication skills. - Advanced


• Proficiency in MS Word/Excel/Powerpoint. - Advanced


• Multi-tasking. -

Specialized Knowledge:

• Basic Analytical Knowledge desirable.


• 21 CFR, cGMP, basic manufacturing process knowledge.