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Validation Engineer,Technical Services

Company: Amneal Pharmaceuticals, Inc.
Location: Brookhaven
Posted on: May 3, 2021

Job Description:

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.

Keywords: Amneal Pharmaceuticals, Inc., Westport , Validation Engineer,Technical Services, Other , Brookhaven, Connecticut

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