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Cleaning Validation Engineer

  • The Cleaning Validation Engineer is responsible for the site's equipment cleaning validation program.
  • Essential Duties and Responsibilities:
  • Lead development and maintenance of cleaning validation program
  • Create cleaning cycle development strategies for a variety of equipment including: process vessels, clean-inplace systems, packaging equipment, parts washers, and production facilities.
  • Write validation protocols and reports in support of the site's validation program
  • Lead investigation and troubleshooting problems which occur during cleaning
  • Responsible for planning and execution of onsite cleaning validation programs compliant with US FDA
  • requirements.
  • Prepare and review completed and executed validation packages by compiling and analyzing validation data
  • for submittal for review and approval
  • Lead resolution of cleaning deviations through technical knowledge, execution of supporting validation studies,
  • and manufacturing documentation review and approval
  • Develop and author change controls for cleaning process or equipment changes
  • Write and execute IQ/OQ/PQ/ and cycle development protocols including development of final reports.
  • Maintain an up-to-date knowledge of validation requirements, practices, and procedures
  • Write validation plans and risk assessments related to specific projects and facilities
  • Write and review policies and procedures (SOPs)
  • Facilitate the development of user requirement specifications and operational SOPs for equipment.
  • Perform risk assessment and gap analysis for site cleaning programs.
  • Lead cleaning studies, spray coverage testing, cleaning verification swabbing, and risk sampling.
  • Lead continuous improvement activities related to cleaning and changeover optimization
  • Responsible for identifying appropriate facility cleaning/sanitizing agents; participates in cleaning/sanitizing
  • effectiveness studies
  • Other duties as assigned
  • The Cleaning Validation Engineer may be responsible for coordinating the activities of two (2) or more team members.
  • The Cleaning Validation Engineer has the authority to correct process behaviors that violate department standards on the floor.
  • This job has no supervisory responsibilities.
  • 2+ years of Cleaning Validation experience
  • Graduate degree in related field or 2+ years Cleaning Validation experience
  • Bachelor's degree in Engineering or Science
  • 2+ years of Cleaning Validation experience in an FDA 21 CFR regulated industry