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Validation Engineer II

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

Job Description:

Description:

  • The Validation Engineer II is responsible for performing validation and Engineering activities, conducting development studies, analyzation and assist in improving pharmaceutical systems and processes.

Essential Functions:

  • 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
  • Performs re-qualification of equipment, facility and utilities as required
  • Responsible for creating validation project and validation progress reports - weekly and monthly
  • Participate in evaluation of failures and out of specification results impacting compliance with quality, safety and other design requirements
  • Provide Technical Inputs and develop strategy for various domestic and international Site Transfer projects. Provide regular status updates to the department and program management.
  • Closely works with the maintenance & facility teams to complete new equipment installation, commission and validation as per project requirement.
  • Performs engineering assessment and writes investigation reports for non-conformance

Additional Responsibilities:

  • Assists with engineering projects and performs other duties as assigned.

Education:

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

Experience:

  • 2 years or more in 2-5 years experience in engineering, pharmaceutical industry, cGMP environment

Skills:

  • Proficient in MS Office. - Advanced
  • Excellent technical writing skills - Intermediate
  • 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:

  • Read, understand and verify piping & instrument diagram, engineering layout, drawing and documents

Licenses:

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

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