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Validation Engineer III

Company: Amneal Pharmaceuticals, Inc.
Location: Brookhaven
Posted on: June 12, 2021

Job Description:

Description:

  • The Validation Engineer III performs validation and engineering activities; conducts development studies; and monitors, analyzes and assists in improving pharmaceutical systems and processes. Provides detailed reports to management.

Essential Functions:

  • Design, develop and execute validation documents, define validation strategy.
  • Design, review and execute validation document activities such as Factory acceptance test (FAT), Installation qualification (IQ), Operational qualification (OQ), Performance qualification (PQ) for equipment/utilities/facilities and generate reports which summarize results, specification and its acceptance criteria
  • Prepare and review various documents using QUMAS software.Provides technical expertise for investigation and resolution of process deviations, development and interpretation of data trending, initiation and review of change controls.
  • Develops User Requirements Specification (URS) and Design Specifications.
  • Oversee the collection of equipment manuals from vendors and other required documents as well as Factory Acceptance Test (FAT) execution.
  • Design and develop test strategy and methodology for the validation of complex equipment.
  • Manage GMP documentation by supporting cGMP programs including: Risk Analysis, Change Control, and Standard Operating Procedure and Notice of Investigation (NOI)/Corrective Action and Preventative Action (CAPA).
  • Partner with management, technical peers, and negotiate with vendors to gain consensus on design, testing and methodology.
  • Develops/updates operational and engineering related standard operating procedures to comply with cGMP and regulatory requirements.

Additional Responsibilities:

  • Assist with Engineering projects as needed. Supervise and train staff as needed. Perform other duties as assigned.

Education:

  • Bachelors Degree (BA/BS) Degree in Pharmaceutical manufacturing, Engineering, Science or relevant field - Required

Experience:

  • 5 years or more in 5 or more years relevant experience in Engineering, pharmaceutical industry, cGMP environment with bachelors

Skills:

  • Proficient in MS Office. - Advanced
  • Excellent technical writing skills. - Advanced
  • Excellent oral and written communication skills. - Advanced
  • Must be able for follow direction and execute assigned work independently, after initial training is completed. - Advanced
  • Ability to work both independently and in conjunction with a team - Advanced

Specialized Knowledge:

  • Knowledge of Good Documentation Practices, Engineering Qualification Procedures a must. Reads, understands and verifies piping & instrument diagram, engineering layout, drawing and documents.

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

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