Commissioning, Qualification, and Validation Expert

3 days ago

Bikaner, Rajasthan, India beBeeValidation Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Senior CQV Trainer

We are seeking a highly experienced Commissioning, Qualification, and Validation (CQV) engineer to join our team.

  • CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.
  • Development and review of CQV documentation, including User Requirements Specification (URS), Design Qualification (DQ), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and risk assessments (Failure Mode Effects Analysis - FMEA).
  • Validation master plans (VMP) and system impact assessments.

This role involves preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment. The ideal candidate will support global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including GxP standards.

Mentor junior CQV engineers, subject matter expert in audits and inspections.

Required qualifications:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
  • 10+ years hands-on CQV experience in pharma and/or medical device industries.
  • Deep understanding of regulatory requirements.
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.

Preferred qualifications:

  • Experience with sterile manufacturing, biologics, cell/gene therapy, or combination products.
  • CQV experience in greenfield or brownfield capital projects.
  • Knowledge of Agile, Lean Six Sigma, project management certifications.

Tools & Platforms:

  • Veeva Vault, ValGenesis, TrackWise, Kneat Gx.
  • Microsoft Office Suite, MS Project, SharePoint.
  • Remote collaboration tools.

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