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Senior Validation Engineer

Company: Hunter International Recruiting
Location: Akron
Posted on: February 23, 2021

Job Description:

Senior Validation EngineerCompetitive Salary & Benefits Offered Our client facility is seeking a Senior Validation Engineer who is responsible for demonstrating hands-on experience in developing and executing specifications, operating procedures, commissioning/qualification/validation protocols and reports to maintain "Systems" in validated state. Provide expertise for projects involving sterile operation and process packaging equipment as well as facility, utilities and computerized systems (CSV) validation program. Senior Validation Engineer Responsibilities:

  • Demonstrate skills set, knowledge and apply ASTM E2500 principles, and good engineering practices to the Site Validation Lifecycle concept.
  • Author, review, and execute commissioning, qualification (C&Q) and validation documentation.
  • Maintain Equipment/Facility/Utility (EFU) and computer validation program in accordance with Validation Master Plans and corresponding SOPs.
  • Ensure that C&Q and Validation project deliverables (i.e., Specification, SOPs; Protocols/Reports; Risk Assessment; Tracebility Matrix, etc.) are compliant with the current regulations, current industry practices, and internal policies and procedures.
  • Execute and/or provide support with C&Q and validation activities of cross functional teams including MS&T, Engineering, Operations (sterile/non-sterile), and Quality as applicable.
  • Author of valid systems' inventory to maintain periodic review scheduling and revalidation program.
  • Apply a science and risk-based approach for "Systems" qualification activities to assess the need and/or extent of required validation efforts.
  • Generate and resolve qualification / validation protocol discrepancies/deviations and/or other impact investigation incidents.
  • Manage relationship with internal client group of operations, ensuring Xellia CLE manufacturing & packaging equipment and its processes are validated and in compliance for manufacturing.
  • Can be responsible to define C&Q, Validation requirements for technical transfer and/or new product/process introduction. Senior Validation Engineer Requirements:
    • Bachelor's degree in Engineering, Life Sciences, or related discipline (Chemical Engineering, Chemistry, Biology, Electrical, Mechanical, etc.).
    • A minimum of seven (7) years of hands-on, direct validation experience in pharmaceutical / biotech industries.
    • Champion to adopt / apply principles of ASTM E2500 (Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Systems and Equipment).
    • Recent and relevant to Sterilization Qualification, VHP Decontamination processes experiences, including EFU, packaging equipment and CSV validation.
    • Knowledge in writing, reviewing and executing C&Q, validation protocols and technical reports (including user/functional/design specifications).
    • Experience in change control process.
    • Working knowledge of applied risk assessment tools.
    • Understand potential risk areas / shortfalls to deliver validations right first time.Senior Validation Engineer Preferred Skills:
      • Expertise with Isolator technology and sterile operations.
      • Demonstrate ability to read, comprehend and interpret equipment manuals, P&ID's, mechanical and electrical drawings and PLC logic.
      • Demonstrate skills in troubleshooting critical process or equipment issues.
      • Proven mechanical aptitude preferred:
      • Technology transfer / New Product/Process Introduction
      • Process development / Process improvements (Design Of Experiments, DOE).
      • Knowledge in serialization / aggregation process and packaging validation

Keywords: Hunter International Recruiting, Akron , Senior Validation Engineer, Engineering , Akron, Ohio

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