GxP Validation Engineer

Job Summary:

The GxP Consultant / Client-Facing Validation Engineer is responsible for delivering end-to-end validation and compliance consulting services to pharmaceutical, biotechnology, and medical device clients.

This role combines Computer System Validation (CSV) with Equipment, Utilities, and Facilities Qualification, ensuring compliance with global regulatory standards including U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), 21 CFR Part 11, EU Annex 11, and GAMP 5 principles.

The consultant acts as a trusted client advisor, ensuring systems, processes, infrastructure, and manufacturing assets are validated, audit-ready, and continuously compliant.

Roles and Responsibilities:

• Act as primary validation contact for clients.
• Conduct validation discussions, project status meetings, and workshops.
• Support client audits, inspections, and compliance reviews.
• Execute validation lifecycle activities for GxP systems.
• Prepare validation documentation including:
  
  • Validation Plan
  • Risk Assessment
  • Software Assessment
  • User Requirements Specifications (URS)
  • Functional Requirements Specifications (FRS)
  • IO / OQ / PQ Protocols
  • Traceability Matrix
  • Validation Summary Report
  • Support qualifications of pharmaceutical manufacturing and laboratory equipment
  • Review FAT/SAT documentation and support equipment validation activities
• Support qualification of utilities and facilities systems including:
  
  • HVAC systems
  • Cleanrooms
  • Water systems (PW/WFI)
  • Compressed air systems
  • Environmental monitoring systems
• Change Control Management:
  
  • Perform validation impact assessments for system or equipment changes
  • Update validation documentation and testing requirements
  • Support Change Control processes and revalidation activities
• Documentation & eDMS Management:
  
  • Manage validation documentation in eDMS platforms
  • Ensure document version control, approval workflows, and audit readiness

Qualifications:

• Bachelor's degree in Pharmacy, Chemical Engineering, Mechanical Engineering, E & TC or Biotechnology
• 4+ years of experience in:
  
  • CSV
  • Equipment Qualification
  • Utilities/Facilities Validation
• Strong knowledge of:
  
  • GAMP 5
  • Risk-based validation
  • GMP regulations
  • Data Integrity principles
• Experience in pharmaceutical manufacturing environments

Benefits:

• Competitive salary and benefits package.
• Opportunity to work on cutting-edge AI/ML projects with real-world impact.
• Collaborative and supportive work environment.
• Continuous learning and development opportunities.

Note: Candidates selected for this position should be willing to work hybrid or shift to Nashik location as the role requires onsite presence.

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