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Associate Process Engineer at Amneal India
Piscataway, New Jersey, United States -
Full Time

Start Date

Immediate

Expiry Date

12 Mar, 26

Salary

0.0

Posted On

12 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Process Validation, Cleaning Validation, Data Analysis, Statistical Analysis, Manufacturing Process, Troubleshooting, Deviation Investigations, Corrective Actions, Preventative Actions, Audit Assistance, Protocol Preparation, Report Preparation, Batch Record Review, Trend Analysis, Quality Standards, Engineering Qualification

Industry

Pharmaceutical Manufacturing

Description
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.
Responsibilities
The Associate Process Engineer is responsible for preparing validation protocols and reports for manufacturing and cleaning processes. They also analyze statistical data to ensure conformance with quality standards and assist in investigations to identify root causes.