Senior Validation Specialist

7 hours ago

India beBeeValidation Full time ₹ 15,00,000 - ₹ 28,00,000

Job Title: Senior Validation Specialist

Overview:

We are seeking a seasoned validation professional with extensive experience in commissioning, qualification, and validation activities across the pharmaceutical and medical device sectors. The ideal candidate will provide expert-level support to global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including GxP standards.

About the Role:

This senior role involves preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment. Key responsibilities include leading and executing CQV activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.

The successful candidate will develop and review CQV documentation, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA). They will also manage and implement validation master plans (VMP) and system impact assessments.

The ideal candidate will collaborate with cross-functional teams to ensure seamless CQV integration into capital and remediation projects. This includes conducting remote FAT/SAT support, data review, and validation strategy planning. They will also oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.

Achieving 21 CFR Part 11 compliance for computerized systems is also essential for this role. Furthermore, the candidate must drive continuous improvement and risk-based validation strategies in line with current industry best practices.

In addition to these responsibilities, the candidate will mentor junior CQV engineers and act as a subject matter expert (SME) in audits and inspections.

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).
  • 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.

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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