CSV Engineer

VRR Life Sciences; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

VRR Life Sciences is seeking an experienced Computer System Validation (CSV) professional in Bengaluru, India to support validation activities for GxP-regulated computerized systems. This role involves ensuring regulatory compliance and working with cross-functional teams.

Key responsibilities include performing validation activities, preparing validation documentation, and supporting the validation of systems like LIMS, QMS, and ERP. The ideal candidate should have a degree in Lifesciences or Pharmacy and 1-7 years of relevant experience.

Qualifications

• 1-7 years of hands‑on experience in Computer System Validation within regulated environments.
• Strong understanding of regulatory requirements and guidelines (GAMP 5, 21 CFR Part 11, EU Annex 11).
• Excellent documentation and communication skills.

Responsibilities

• Perform validation activities for GxP computerized systems.
• Prepare and review validation documentation.
• Support validation of systems such as LIMS, QMS, ERP, and laboratory instruments.

Skills

Computer System Validation

Regulatory compliance

Data integrity principles

Education

Bachelors or Masters degree in Lifesciences, Pharmacy, Biotechnology or related field

Tools

LIMS

QMS

ERP

Job description

Industry: Pharmaceutical / Biotechnology / Lifesciences

About the Role:

We are looking for an experienced Computer System Validation (CSV) professional to support validation activities for GxP-regulated computerized systems. The role involves executing validation deliverables, ensuring regulatory compliance, and working closely with cross-functional teams to maintain system integrity throughout the lifecycle.

Key Responsibilities:

• Perform validation activities for GxP computerized systems (planning, risk assessment, summary reports).
• Prepare and review validation documentation including URS, FRS, RA, IQ, OQ, PQ, and Traceability Matrix.
• Support validation of systems such as LIMS, QMS, ERP, MES, CDS, and laboratory instruments.
• Contribute to SOP creation and updates related to computerized systems.
• Execute and support CSV activities in line with GAMP 5, 21 CFR Part 11, EU Annex 11, and company SOPs.
• Perform risk assessments and data integrity evaluations.
• Support change control, periodic reviews, and deviation management for validated systems.
• Participate in regulatory audits and inspections and provide CSV-related responses.
• Conduct impact assessments and periodic reviews for existing validated systems.
• Collaborate with QA, IT, and business users to ensure validation deliverables are met within timelines.
• Ensure data integrity compliance across systems and processes.

Key Requirements:

• Bachelors or Masters degree in Lifesciences, Pharmacy, Biotechnology, or related field.
• 1 –7 years of hands‑on experience in Computer System Validation within regulated environments.
• Strong understanding of regulatory requirements and guidelines (GAMP 5, 21 CFR Part 11, EU Annex 11) Experience with validation of ERP, LIMS, QMS, or other laboratory/manufacturing systems preferred.
• Experience validating GxP systems and laboratory equipment.
• Excellent documentation and communication skills.
• Ability to work independently and in cross‑functional teams.
• Familiarity with data integrity principles (ALCOA+).