Senior CQV Specialist

5 days ago

Coimbatore, Tamil Nadu, India beBeeValidation Full time ₹ 30,00,000 - ₹ 40,00,000
Job Title: Senior Commissioning, Qualification and Validation (CQV) Specialist

We are seeking a highly experienced CQV professional with over 10 years of proven expertise in Commissioning, Qualification, and Validation activities across the pharmaceutical and medical device sectors.

This role involves the 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.

  • Lead and execute CQV activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation including User Requirements Specification (URS), Design Qualification (DQ), Functional Performance Qualification (FAT), Site Acceptance Testing (SAT), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and risk assessments (e.g., Failure Mode Effects Analysis (FMEA)).
  • Manage and implement validation master plans (VMPs) and system impact assessments.
  • Collaborate with cross-functional teams (engineering, quality assurance, manufacturing, IT) to ensure seamless CQV integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with Good Automated Manufacturing Practice (GAMP) 5, FDA, EMA, and ISO 13485 (for medical devices) requirements.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.
  • Mentor junior CQV professionals and act as a subject matter expert (SME) in audits and inspections.

Key Responsibilities:

  • Commission, qualify, and validate manufacturing equipment, utilities, and computerized systems.
  • Develop and review CQV documentation.
  • Implement validation master plans and system impact assessments.
  • Collaborate with cross-functional teams.
  • Conduct remote FAT/SAT support and data review.

Required Skills and Qualifications:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on CQV experience in the pharma and/or medical device industries.
  • Deep understanding of regulatory requirements (FDA, EU Annex 15, ICH Q8-10, ISO 13485).
  • Expertise in GAMP 5, 21 CFR Part 11, and risk-based validation.
  • Experience working in remote project environments.
  • Proficient in using validation lifecycle software and document management systems.
  • Excellent communication and technical writing skills.

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, or project management certifications (e.g., PMP).
  • Prior experience working with global, cross-cultural teams remotely.

Tools & Platforms:

  • Veeva Vault, ValGenesis, TrackWise, Kneat Gx.
  • Microsoft Office Suite, MS Project, SharePoint.
  • Remote collaboration tools (MS Teams, Zoom, Slack).

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