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Validation Specialist

Company: Accentuate Staffing
Location: Wilson
Posted on: November 12, 2021

Job Description:

Accentuate Staffing is seeking a Validation Specialist to work with a company in Wilson, NC. The ideal candidate has previous experience working in pharmaceutical validation combined with a strong background in sterilization and equipment manufacturing. This position would pay based on level of experience. Responsibilities:

  • Developing and Executing Validation Plans, Test Executions, Risk Assessments, Trace Matrices and IQ/OQ/PQ Protocols
  • Sterilization of filled flexible containers
  • Performing thermal validations/temperature mapping and data analysis for ---sterilization cycles
  • Execute validation strategies according to established site, industry and regulation standards Requirements:
    • BS in Engineering or a related scientific field
    • Minimum of 3 to 5 years of GMP regulated industry experience
    • Must have demonstrated experience with pharmaceutical validation, sterilizer (autoclave) and filling equipment qualifications
    • Strong technical writing skills
    • Manufacturing equipment experience Job Requirements:
      • Integrate test equipment and test software to support software validation/verification
      • Implement software product validation tests
      • Beginning computerized system validation activities
      • Assist with defining validation strategy
      • Communicate validation roadblocks or challenges
      • Maintain business wide validation practices
      • Create and maintain validation test plan and specific validation features required for each product
      • Evaluate computer system validation and system development lifecycle (CSV & SDLC)
      • Perform validation assessments of new and existing software to determine the level of validation
      • Oversee user testing and ensure validation testing is conducted
      • Provided validation packages and develop validation strategy by aligning with the clients standards
      • Assure proper understanding of validation activities
      • Setting and maintaining computerized system validation standards via computerized system validation SOPs
      • Develop test methodologies for validation/verification of system and subsystem software performance
      • Set and meet lead times for validation testing
      • Develop validation designs including alternatives to manual testing
      • Develop validation methods and procedures including automated testing
      • Analyze and act upon metrics from validation testing
      • Develop a validation strategy and project plan
      • Generate and maintain cleaning validation master plans

Keywords: Accentuate Staffing, Wilson , Validation Specialist, Other , Wilson, North Carolina

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