Senior Validation Expert

15 hours ago

Erode, Tamil Nadu, India beBeeValidation Full time ₹ 90,00,000 - ₹ 1,20,00,000
Job Title: Senior CQV Trainer

We are seeking an accomplished Senior Commissioning, Qualification and Validation (CQV) Professional with extensive expertise in delivering high-quality training programs for pharmaceutical and medical device sectors.

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

Key Responsibilities:

  • 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 URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams (engineering, QA, 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 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 engineers and act as a subject matter expert (SME) in audits and inspections.

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 Skills and 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)

Benefits:

This role offers a unique opportunity to develop your skills and expertise in CQV, while contributing to the success of our organization. You will have the chance to work with a talented team of professionals, and be part of a dynamic and fast-paced environment.

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