Validation Specialist in Cleaning Processes

2 weeks 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 experienced Cleaning Validation Engineers to enhance our operations. This position involves the practical execution of cleaning validation tasks within a Good Manufacturing Practice (GMP) and aseptic setting, with a focus on sterilization and fill-finish apparatus.

Key Qualifications:

  • 2-8 years of expertise in cleaning validation.
  • Experience working in GMP and aseptic settings.
  • Practical knowledge of sterilization and fill-finish equipment.
  • Proficient technical writing abilities.
  • Familiarity with ValGenesis digital validation tools.

Core Responsibilities:

  • Formulate, implement, and/or assess master and finalized qualification and validation protocols, summary reports, and associated data to ensure adherence to regulations, standard operating procedures (SOPs), specifications, and other pertinent acceptance criteria.
  • Evaluate test outcomes and determine their compliance with established standards.
  • Investigate and resolve discrepancies, offering solutions or recommendations for modifications and enhancements.
  • Review, modify, and authorize deviation notifications, investigations, and corrective measures.
  • Review, modify, and authorize change controls, SOPs, reports, and other documentation.
  • Collaborate with various departments or external contractors/vendors to fulfill validation objectives.
  • Provide training and guidance to less experienced professionals.
  • Oversee projects and prepare progress reports.


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