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Validation Specialist in Cleaning Processes

2 months ago

New York, New York, United States Medix™ Full time

Cleaning Validation Engineer

Location: Rensselaer, NY

Shift: Saturday-Wednesday OR Sunday-Wednesday, 10AM-8PM

Pay: $55-85/HR, based on experience

Duration: 3-5 Year CONTRACT with benefits

Medix™ is seeking skilled Cleaning Validation Engineers to enhance our operations at the Rensselaer facility. This position is crucial for executing cleaning validation tasks within a GMP and aseptic framework, particularly concerning sterilization and fill-finish machinery. Candidates must possess robust technical writing capabilities and be well-versed in ValGenesis digital validation software utilized in the life sciences sector.

Key Qualifications:

  • 2-8 years of expertise in cleaning validation.
  • Experience in GMP and aseptic settings.
  • Practical knowledge of sterilization and fill-finish machinery.
  • Exceptional technical writing abilities.
  • Familiarity with ValGenesis software.

Core Responsibilities:

  • Develop, execute, and/or review master and completed qualification and validation protocols, summary reports, and related data to ensure adherence to regulations, SOPs, specifications, and other relevant acceptance criteria.
  • Analyze test outcomes and evaluate their acceptability against established criteria.
  • Investigate and resolve issues, providing solutions or recommendations for changes and enhancements.
  • Review, edit, and approve deviation notifications, investigations, and corrective actions.
  • Review, edit, and approve change controls, SOPs, reports, and other documentation.
  • Collaborate with other departments or external contractors/vendors to complete validation tasks.
  • Provide training and mentorship to less experienced specialists.
  • Manage projects and prepare status reports.