GxP Validation Engineer

xLM, LLC; Nashik District, Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

xLM, LLC in Nashik is seeking a GxP Validation Engineer to drive end-to-end validation and compliance consulting for pharma, biotech, and medical device clients. You will deliver CSV with equipment and facilities qualification, ensuring systems meet regulatory standards and audit readiness.

Minimum 4+ years in validation, CSV, or qualification, with experience in GMP, data integrity, and risk-based validation.

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, and data integrity principles.

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 Plan, URS/FRS, IO/OQ/PQ protocols, and traceability matrices.
• Review FAT/SAT documentation and support equipment validation activities.
• Support qualification of utilities and facilities systems including HVAC, cleanrooms, water systems, compressed air, and environmental monitoring.
• Manage validation documentation in eDMS platforms with proper version control.

Skills

GxP Validation

CSV

Documentation

Regulatory knowledge

eDMS

Education

Pharmacy

Chemical Engineering

Mechanical Engineering

Biotechnology

Tools

eDMS

FAT/SAT

Job description

xLM's mission is to transform how life sciences companies manage compliance, quality, and operations through AI-powered intelligence. We want our technology to be safe, reliable, and beneficial for our customers and for the industry as a whole. Our team is a growing group of committed engineers, domain experts, and business leaders working together to build the future of intelligent GxP compliance.

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. Minimum 4+ years of relevant GxP validation, CSV, or qualification experience. 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.
• Validation Plan
• 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.
• 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 shift to Nashik location as the role requires onsite presence.