CSV Consultant - Manufacturing Validation
Experience: 6-10 Years

Role Summary

We are looking for a hands-on Computer System Validation (CSV) Consultant with robust experience in pharma / biotech / medical device manufacturing environments. This role requires a candidate with end-to-end CSV project execution experience, especially in manufacturing validation and QMS-regulated systems.

The ideal candidate should have proven experience validating systems such as MES, SAP, TrackWise, ServiceNow, or Veeva Vault, along with exposure to bio-clinical systems like CTMS, EDC, or Lab systems.

Core Requirement

The candidate must have:
• Strong end-to-end CSV project experience
• Proven experience in manufacturing validation environments
• Hands-on validation exposure on systems such as:
• MES
• SAP
• TrackWise
• ServiceNow
• Veeva Vault
• Exposure to bio-clinical systems such as:
• CTMS
• EDC
• Lab systems
• Good understanding and practical experience in QMS processes
• Stable career progression within CSV / validation / compliance roles

Key Responsibilities

Computer System Validation




• Execute end-to-end CSV lifecycle activities across regulated systems
• Lead/support IQ, OQ, PQ activities
• Prepare, review, and execute validation deliverables such as:
• Validation Plan
• URS
• FRS
• Risk Assessments
• RTM
• Validation Summary Report
• Ensure validation activities are aligned with regulatory and internal quality expectations

Compliance and Regulatory
• Work within GxP-regulated environments
• Ensure compliance with:
• 21 CFR Part 11
• GAMP 5
• ICH Q9
• Support GxP assessments, functional risk assessments, and audit readiness
• Participate in regulatory, internal, and client audit support activities

Manufacturing / QMS / System Validation
• Perform validation in pharma manufacturing / medical device validation environments
• Support validation of systems linked to manufacturing, quality, and clinical processes
• Work on QMS-related workflows, deviations, CAPA, change c

📌 CSV Consultant (India)
🏢 TRUGlobal
📍 India