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Validation Engineer

The Validation Engineer owns, coordinates, and manages the CTK Master Validation activities for equipment, process, and software per the Validation Procedure and applicable industry regulations, standards, and guidance documents.

  • Manage, own, and lead CTK’s Master Validation Plan (MVP) Program
  • Author and/or assist in authoring equipment, process, and software V&V protocols
  • Execute and/or assist with executing validations protocols
  • Author, review, and approve validation/verification reports
  • Perform training, coaching, and mentoring of others on best practices for conducting V&V activities
  • Provide guidance and recommendations on validation strategies
  • Continuous monitoring of production process and equipment using the MVP and other tools as necessary
  • Maintain the MVP Listing and Log to reflect the current status of validations
  • Maintain documentation and records in an accurate and timely fashion
  • Represent and explain the validation program during agency and customer audits
  • Other duties as assigned
  • BA degree, completed or in progress, or relevant experience in biology, chemistry, or related field
  • 5+ years of experience in IVD/Reagent/Antigen Production and/or laboratory setting
  • 5+ years of experience performing validations, writing V&V protocols/reports
  • 5+ years of hands-on experience with electromechanical equipment and processes
  • Working experience with FDA’s GMP/QSR and/or ISO 13485
  • Knowledge and ability to use Microsoft Office, including Excel Spreadsheets, Word, PowerPoint, etc.
  • Excellent attention to detail and good organizational skills
  • Ability to write clear and concise procedures and other documents
  • Ability to convey detailed information in English orally and in writing
  • Good problem-solving and troubleshooting skills
  • Ability to multi-task
  • Ability to work in a team environment

Please email your resume to Leona  Evaristo at levaristo@ctkbiotech.com

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