Associate Process Engineer
Amneal New Jersey•Piscataway Township, NJ
7h
About The Position
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.
Responsibilities
- 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
- 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.
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What This Job Offers
Job Type
Full-time
Education Level
No Education Listed
