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Sr. Validation Engineer

Company: nxtgen search
Location: Vista
Posted on: February 19, 2021

Job Description:

The Validation Engineer fulfills a critical role in GMP operations. This individual must plan and execute validation studies, write validation protocols, reports and other technical documents, as well as conduct validation related investigations. The incumbent is responsible for managing the cleaning validation activities in a GMP environment including cleaning cycle development, execution of protocols and review and approval of reports. The incumbent will contribute to improvements in operations, processes and methods. QUALIFICATIONS:

  • Bachelor's Degree in science related field (Engineering, chemistry, biology or equivalent)
  • 2-4 years of related experience in Engineering, manufacturing or quality
  • Experience with root cause analysis, failure mode analysis, verification and validation
  • Experience in drug GMP manufacturing
  • Experience in writing standard operating procedures and technical reports
  • Experience in validation, particularly cleaning validation
  • Master's Degree in science related field
  • Six Sigma Green or Black Belt
  • Minimum of 4 years of pharmaceutical validation experience (cleaning, equipment and facilitates/ utilities)
  • Detail oriented with the ability to troubleshoot and resolve problems
    • Provide equipment, facilities/utilities qualification guidance and strategy during project planning and development phases
    • Independently develop cleaning validation strategy for equipment and parts
    • Develop and execute cleaning validation protocols and generate validation reports
    • Independently plan and execute validation studies for equipment, facilities/ utilities and cleaning
    • Manage contractors performing equipment and system qualifications
    • Write validation protocols, validation final reports, Standard Operating Procedures (SOPs), and technical reports
    • Review and approve validation documentation (requirements specifications, risk assessments, validation plans, IQ, OQ, and related reports, and validation summary reports, etc.) using defined procedures
    • Independently conduct and document investigations related to validation activities
    • Contribute to GMP systems improvements
    • Train operations staff on protocols, procedures and technical details related to systems, equipment and cleaning processes
    • Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations
    • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies requirements

Keywords: nxtgen search, Vista , Sr. Validation Engineer, Engineering , Vista, California

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