Job Title: Validation Engineer (CQV/CSV)

Des Moines, IA, US • Posted 17 hours ago • Updated 1 hour ago
Full Time
Part Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • GMP
  • Computerized System Validation
  • Life Sciences
  • Chromatography
  • Good Manufacturing Practice
  • Traceability Matrix
  • Regulatory Compliance
  • IQ
  • OQ
  • PQ
  • Manufacturing
  • SANS
  • Documentation

Summary

Overview:

Seeking a Biopharmaceutical Validation Engineer to support commissioning, qualification, and validation (CQV) activities for GMP manufacturing equipment and integrated systems. The role requires a self-driven professional capable of authoring and executing validation documentation independently while ensuring compliance with cGMP standards and regulatory requirements.


Required Experience:

  • 4+ years of CQV and CSV experience within Life Sciences / Biopharmaceutical industry
  • Hands-on experience authoring and executing IQ/OQ/PQ protocols
  • Strong knowledge of biologics manufacturing equipment (TFF, Chromatography, Bioreactors)
  • Experience with cGMP environments and 21 CFR Part 11 compliance
  • Experience developing Validation Summary Reports, Deviation Reports, and Traceability Matrices


Key Responsibilities:


  • Apply risk-based validation methodologies to streamline qualification activities while maintaining quality and compliance.


  • Author, review, and execute commissioning and qualification protocols (IQ/OQ/PQ) for single-use and multi-use manufacturing equipment.
  • Support synchronization of manufacturing equipment and automated systems to ensure compliant operations.
  • Develop and maintain validation documentation in alignment with site SOPs and regulatory standards.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 90737436
  • Position Id: OOJ - 8005-7009-1772720120
  • Posted 17 hours ago
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