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Amneal Pharmaceuticals Validation Engineer,Technical Services in Brookhaven, New York

Description:

  • 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.

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.

Job: *Manufacturing

Organization: *Operations

Title: Validation Engineer,Technical Services

Location: NY-Brookhaven

Requisition ID: 2103H

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