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.
