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Characterization Consultant – CQV / Validation

Intellectt INC

  • New Albany, OH
  • 18 days ago

    Highlights

    Skills: Equipment and process characterization, protocol development and execution, DOE/statistical analysis, root cause analysis and troubleshooting, URS/design documentation, commissioning and equipment qualification, with GMP/pharmaceutical manufacturing experience and preferably assembly or packaging equipment experience. Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

    Numbers & Facts

    LocationNew Albany, OH

    Description

    Job Title: Characterization Consultant CQV / Validation
    Location: New Albany, Ohio
    Work Arrangement: Onsite
    Experience Level: 3 5 Years
    Pay rate: $46-$48/hr on W2

    Skills: Equipment and process characterization, protocol development and execution, DOE/statistical analysis, root cause analysis and troubleshooting, URS/design documentation, commissioning and equipment qualification, with GMP/pharmaceutical manufacturing experience and preferably assembly or packaging equipment experience.

    Job Summary:

    Seeking a CQV/Validation Consultant to support equipment and process characterization for pharmaceutical assembly and packaging equipment.

    Key Responsibilities:

    Develop and execute characterization protocols.
    • Perform equipment/process characterization and engineering runs.
    • Challenge equipment against URS and design requirements.
    • Conduct DOE, parameter mapping, sampling studies, and statistical analysis.
    • Troubleshoot equipment/process issues and perform RCA.
    • Support commissioning, qualification, and equipment readiness.
    • Prepare technical reports and characterization documentation.
    • Collaborate with Engineering, Validation, Quality, and Manufacturing teams.

    Required Skills:

    • Equipment/process characterization
    • Protocol development & execution
    • DOE / statistical analysis
    • Root cause analysis & troubleshooting
    • URS/design documentation
    • Commissioning / equipment qualification
    • GMP/pharmaceutical manufacturing experience
    • Assembly or packaging equipment experience preferred

    Benefits: Eligible employees may have access to benefits offered by Intellectt Inc. in accordance with the applicable benefit plans and eligibility requirements.

    Equal Employment Opportunity: Intellectt Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetic information, veteran status, or any other characteristic protected by applicable federal, state, or local law.

    Thanks & Regards,

    Kunnath Rudra Prasad
    Technical Recruiter
    Intellectt Inc
    prasad.kunnath@intellectt.com
    Direct: 732 200 2726
    Desk number: 732 200 2726 Ext: 189

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