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) qualified 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.
Solid 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.

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