Cleaning Validation Engineer - Program Development

ZP Group-posted 2 months ago
$75 - $85/Yr
Mid Level
Cary, NC
251-500 employees
Professional, Scientific, and Technical Services
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Join a global leader in biopharmaceutical contract development and manufacturing (CDMO), renowned for innovation, scale, and a commitment to quality. As we continue to expand our capabilities and facilities, we are seeking a Cleaning Validation Engineer to lead the development and implementation of a world-class cleaning validation program.

  • Develop and implement a robust cleaning validation program aligned with cGMP, FDA, EMA, and other global regulatory requirements.
  • Lead cleaning validation activities for parts washers, factory parts and components, and isolator filling lines.
  • Author and review cleaning validation protocols, risk assessments, and final reports.
  • Collaborate with cross-functional teams including Quality Assurance, Manufacturing, Engineering, and Regulatory Affairs.
  • Support equipment commissioning and qualification efforts related to cleaning processes.
  • Investigate and resolve cleaning validation deviations and non-conformances.
  • Maintain and improve cleaning validation lifecycle documentation and procedures.
  • Bachelor's or Master's degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences, or a related field.
  • 5+ years of experience in cleaning validation within the pharmaceutical or biopharmaceutical industry.
  • Proven experience developing and executing cleaning validation programs from scratch.
  • Strong understanding of regulatory guidelines (FDA, EMA, ICH, etc.) and industry best practices.
  • Experience with isolator technology and aseptic processing environments is highly desirable.
  • Excellent technical writing, communication, and project management skills.
  • Medical
  • Dental
  • Vision
  • 401K-with match
  • PTO
  • Sick Leave as required by law
  • Holidays
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