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Lonza1 week ago

CQV Engineer

On-site · Bend, Oregon, United States

Type
Full Time
Level
Mid Level
Education
High School Or Equivalent
Company size
Enterprise
Industry
BIOTECH

Job Summary

CQV Engineer to partner with engineering, QA, and manufacturing teams to support smooth project execution; troubleshoot and improve equipment, processes, and systems; write, review, and execute IQ/OQ/PQ for new and existing equipment; identify risks to product quality and apply mitigation strategies; generate validation reports and maintain compliant documentation following FDA and cGMP guidelines; manage and close deviations or non-conformances identified during testing; support engineering documentation such as user requirements and design qualification materials.

Required Qualifications

  • High School Diploma or GED required
  • Engineering degree preferred
  • Experience in CQV and temperature mapping
  • Understanding of FDA, ICH, ISPE, and ISO guidelines
  • Proficiency with Microsoft Word and Excel
  • Ability to solve problems and work cross-functionally
  • Strong communication and documentation skills
  • Interest in improving systems and supporting safe, effective drug development
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Lonza

CQV Engineer

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