Computer System Validation (CSV) Engineer - Mumbai

Computer System Validation (CSV) Engineer Manufacturing Automation

Industry: Pharmaceuticals & Nutritional Manufacturing

Work Location: Mumbai, India (On-site)

Department: Manufacturing Automation

Employment Type: Full-Time

About the Department

The Manufacturing Automation department serves as the vital bridge between technology, regulatory compliance, and operational execution. Comprising Application Managers, Automation Engineers, and MES Designers, the team supports mission-critical computerized systems across production, laboratories, facilities, and utilities to ensure reliable, high-quality, and compliant operations.

Role Overview

As a CSV Specialist, you will serve as the Subject Matter Expert (SME) for Computer System Validation (CSV), Data Integrity, and GMP compliance within Manufacturing Automation. This role is responsible for leading complex validation and implementation projects, setting governance frameworks, and translating evolving global regulations into actionable site standards.

You will work cross-functionally with QA, Operations, Engineering, and IT to maintain compliant lifecycle management across automated systems while driving the sites forward-looking validation and compliance roadmap.

Key Responsibilities

• SME & Governance: Act as the primary CSV SME for automation and computerized systems projects. Establish, maintain, and harmonize CSV standards, policies, and procedural governance.
• Validation Project Leadership: Lead and coordinate end-to-end validation lifecycle activities for complex automation implementations, upgrades, and integrations across production, MES, and lab environments.
• Regulatory Translation & Strategy: Interpret and embed emerging standards and regulations into site operations, including CSA (Computer Software Assurance), EU GMP Annex 11, and NIS2 / OT Cybersecurity requirements.
• Documentation & Lifecycle Management: Author, review, and coordinate compliant validation deliverables (Validation Plans, URS, FRS, IQ/OQ/PQ protocols, and Summary Reports) aligned with GAMP 5 principles.
• Quality & Compliance Oversight: Manage deviations, test exceptions, non-conformances, and CAPAs related to automated systems, driving robust root-cause investigations.
• Audit & Inspection Readiness: Support regulatory inspections and internal/external audits by defending validation packages and system data integrity controls.
• Stakeholder Advisory & Coaching: Mentor technical colleagues, advise project owners and senior leadership on compliance risks, and ensure reliable reporting on system validation status.

Qualifications & Experience

• Education: Bachelor’s or Master’s degree in Process Engineering, Automation & Control, Business Information Technology, Computer Science, or a related technical discipline.

• Experience: 3 to 5+ years of dedicated CSV experience within a regulated GMP / Life Sciences environment (pharmaceutical, biotech, or nutritional manufacturing).

• Project Leadership: Demonstrated track record serving as a CSV lead or SME delivering complex system validation projects.

• Regulatory & Framework Knowledge: Strong working knowledge of:

• GAMP 5 (Risk-Based Approach to Compliant GxP Computerized Systems)

• EU GMP Annex 11 and US FDA 21 CFR Part 11

• Data Integrity (ALCOA+ principles)

• CSA (Computer Software Assurance) methodology

• NIS2 directive / OT cybersecurity standards in automation

• Interpersonal Skills: Strong stakeholder management, communication, and advisory skills, with the ability to influence cross-functional teams across technical and quality functions.