Experienced Validation Professional Required

13 hours ago

Mount Abu, Rajasthan, India beBeeValidation Full time ₹ 15,00,000 - ₹ 20,00,000
Senior Validation Specialist

We are seeking a highly experienced and skilled Senior Validation Specialist to join our team.

This role involves the preparation, execution, and lifecycle management of validation documentation for new and existing facilities, utilities, systems, and equipment.

Key Responsibilities:
  • Lead and execute validation activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), and computerized systems in compliance with regulatory and industry standards.
  • Develop and review validation 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 validation 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 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.

Required Qualifications:

  • Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
  • 10+ years of hands-on validation 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.
  • Validation 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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