Computer System Validation(CSV)

Intellics Global Services; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Intellics Global Services in Bengaluru is seeking an experienced Computer System Validation (CSV) Engineer to join our pharma-focused team. The ideal candidate will have hands-on CSV for GxP-regulated systems, with strong knowledge of GAMP 5, 21 CFR Part 11 and EU Annex 11, and experience preparing validation documents across URS, FRS, DS, IQ/OQ/PQ and RTM.

You will collaborate with IT, QA and business stakeholders, perform risk-based validation, ensure audit readiness and support weekend

Qualifications

• Hands-on CSV for GxP-regulated systems.
• Strong knowledge of GAMP 5 guidelines.
• Understanding of 21 CFR Part 11 and EU Annex 11.
• Experience with URS, FRS, DS, IQ/OQ/PQ and RTM.
• Knowledge of risk-based validation and CSA.
• Excellent documentation and stakeholder management skills.

Responsibilities

• Perform CSV activities for GxP-regulated systems.
• Prepare, review, and execute validation documents (URS, FRS, DS, IQ/OQ/PQ).
• Develop and maintain RTM and risk assessments.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11.
• Collaborate with IT, QA and business stakeholders.
• Support critical releases and weekend activities.

Job description

Computer System Validation (CSV) Engineer

Job Title: Computer System Validation (CSV) Engineer / Specialist
Experience: 3–10 Years
Domain: Pharma / Life Sciences / Biotechnology
Employment Type: Full-Time

Job Summary

We are looking for an experienced Computer System Validation (CSV) professional with hands-on experience in validating GxP-regulated computerized systems within the Pharmaceutical, Biotechnology, or Life Sciences industry.

The ideal candidate should have strong knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and risk-based validation methodologies, along with experience in preparing and executing validation documentation throughout the system lifecycle.

Key Responsibilities

• Perform Computer System Validation (CSV) activities for GxP-regulated systems.
• Prepare, review, and execute validation documents, including URS, FRS, Design Specifications (DS), IQ, OQ, and PQ protocols.
• Develop and maintain Requirements Traceability Matrix (RTM).
• Conduct risk assessments and implement risk-based validation strategies.
• Ensure compliance with GAMP 5, 21 CFR Part 11, and EU Annex 11 regulatory requirements.
• Apply Computer Software Assurance (CSA) principles wherever applicable.
• Support system qualification, validation, and periodic review activities.
• Maintain accurate validation documentation and ensure audit readiness.
• Collaborate with cross-functional teams, IT, Quality Assurance, and business stakeholders.
• Support critical releases and weekend activities whenever required.

Mandatory Skills

• Hands-on experience in Computer System Validation (CSV) for GxP-regulated systems.
• Strong knowledge of GAMP 5 guidelines.
• Understanding of 21 CFR Part 11 and EU Annex 11.
• Experience with URS, FRS, DS, IQ/OQ/PQ, and RTM.
• Knowledge of risk assessments and risk-based validation.
• Understanding of Computer Software Assurance (CSA).
• Excellent documentation, communication, and stakeholder management skills.
• Flexibility to support critical releases and weekend activities as required.

Preferred Industry Experience

• Pharmaceutical
• Biotechnology
• Life Sciences
• Healthcare / Medical Devices

Ideal Candidate Profile

Candidates with experience in CSV, GxP compliance, computerized system validation, and pharmaceutical regulatory environments will be preferred.