Senior Validation Engineer Trainer

4 days ago

Kannur, Kerala, India beBeeValidation Full time ₹ 1,20,00,000 - ₹ 1,50,00,000
Senior Validation Engineer Trainer

We are seeking an experienced professional to lead and execute validation activities for manufacturing equipment, utilities, and computerized systems in compliance with regulatory and industry standards.

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

Key Responsibilities:

  • Develop and review validation protocols, including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments.
  • Manage and implement validation master plans and system impact assessments.
  • Collaborate with cross-functional teams to ensure seamless integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 requirements.

Required Skills and Qualifications:

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

Benefits:

  • Opportunity to work on diverse projects and contribute to the development of validation strategies.
  • Collaborative team environment with opportunities for professional growth and development.

Others:

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

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