Cleaning Validation Engineer

Stark Pharma Solutions Inc
North Carolina

Position: Cleaning Validation Engineer
Location: North Carolina
Experience: 5 8 years (10 years maximum considered)

Role Overview:
We are seeking a skilled Cleaning Validation Engineer with hands-on experience in commissioning and validating water generation systems, clean steam generation systems, distribution systems, storage tanks, and process gas/air systems. The ideal candidate will have experience across the full Cleaning Validation lifecycle, including specification review, vendor document review, field verification, commissioning document drafting and execution, sample testing, protocol preparation, and summary report drafting.

Key Responsibilities:

  • Execute and oversee cleaning validation projects for greenfield and existing systems.

  • Review and approve specifications and vendor documentation.

  • Conduct field verification and commissioning activities.

  • Draft and execute commissioning and cleaning validation protocols.

  • Analyze and document sample testing results.

  • Prepare summary reports and maintain compliance documentation.

  • Support small parts SME needs and technical data review as required.

Required Skills & Experience:

  • 5 8 years of experience in cleaning validation (up to 10 years acceptable).

  • Hands-on experience with CIP/COP cleaning validation.

  • Familiarity with Kneat software for validation management.

  • Experience in technical writing and reviewing validation documents.

  • Ability to work efficiently in a fast-paced, dynamic environment.

  • Greenfield project experience is a plus.

Nice to Have:

  • Advanced technical writing skills for cleaning validation documentation.

  • Experience reviewing technical data and vendor documentation.

Posted 2025-10-09

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