Computer System Validation (CSV) Engineer

Job Title: Computer System Validation (CSV) Engineer / Specialist

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 solid 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.

📌 Computer System Validation(CSV) (Bengaluru)
🏢 Intellics Global Services
📍 Bengaluru