Senior Validation Specialist

8 hours ago

Rajahmundry, Andhra Pradesh, India beBeeValidation Full time US$ 1,25,000 - US$ 1,75,000
Senior Commissioning and Validation Engineer Trainer Role

This senior-level position requires a seasoned professional with extensive experience in commissioning, qualification, and validation activities. The ideal candidate will possess over 10 years of hands-on expertise in the pharmaceutical and medical device sectors.

About the Job

We are seeking a highly experienced Senior CQV trainer to support global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including GxP standards.

Main 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.
Requirements

To be successful in this role, you should have:

  • 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

The following qualifications are desirable:

  • 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

Familiarity with the following tools is an advantage:

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

This is a fantastic opportunity to leverage your expertise and work collaboratively with cross-functional teams to drive success in our organization.

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