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Validation Engineer

Company: Union Agener, Inc.
Location: Augusta
Posted on: August 6, 2022

Job Description:

Job Description - Validation Engineer Supervisor Title: -Validation Team Lead Position Type: Full timeLocation: Union Agener, Inc. -- Augusta, GA 30901 - -Position Description and Responsibilities: - - - - - - - - -The Validation Engineer leads validation efforts associated with the operation of the site. Primary areas of focus includes equipment qualification, commissioning activities, projects. - - - - - - - - -Develop, write, review and execute validation protocols and reports, risk assessments, SOP's, -validation plan for individual projects, URS, commissioning documents, installation, operation and performance qualification protocols and reports. - - - - - - - - -Leads validation work arising from change controls, capital projects, shutdown and also ongoing revalidation programs if necessary. Background in root cause analysis, OOS investigations and CAPA. - - - - - - - - -Provide validation subject matter expertise to multi-function teams, advises operations on validation matters, and participate in regulatory audits as validation SME. - - - - - - - - -Analyze data generated during validation and determine suitability and quality attributes. - - - - - - - - -Initiate, investigate and report on validation discrepancies and deviations. - - - - - - - - -Train other personnel to assist in the execution of validation activities; provide oversight during execution. - - - - - - - - -Coordinate validation execution with various units including process engineers, validation specialist and operations.

  • Prepare/Review site quarterly and annual product quality review using statistics methods. -Minimum Qualification (education, experience and/or training, required certifications):Education:
    • BA/BS degree in Engineering (ME, EE, or Chem. E), related physical science or equivalent work experience required.
      Experience:
      • Minimum of three years Pharmaceutical/Biomedical/Biotechnology manufacturing experience
      • Two years previous process, equipment and facility validation experience
        Special Skills: - - - - - - - - -Ability to demonstrate flexibility to meet business needs/priorities - - - - - - - - - -Strong computer skills are essential including Word, Excel, and PowerPoint, Good interpersonal skills, teamwork, planning, organization and prioritizing are essential. - - - - - - - - -Expertise strongly desired in the following areas:
        • OQ and PQ
        • Commissioning

        • Working knowledge of cGMPs, product lifecycle and validation regulatory requirements/ guidelines understanding strongly desired.
        • Excellent technical writing skills.
        • Working knowledge of statistical process control tools (such as Six Sigma) desired.
        • Ability to participate in and execute risk based decisions.
        • Good interpersonal, verbal communication, writing skills.
        • Must be able to multitask, have initiative and set priorities.
          Qualified Candidates: - - - - - - - - -Qualified candidates must be legally authorized to be employed in the United States. Union Agener does not anticipate providing sponsorship for employment visa status (e.g H-1B or TN status) for this employment position

Keywords: Union Agener, Inc., Augusta , Validation Engineer, Engineering , Augusta, Georgia

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