CSV Engineer / Senior CSV Engineer

DGXPComplianceLab; Hyderabad; On-site; INR 900,000 - 1,400,000; Full time

Job summary

DGXPComplianceLab is seeking a qualified validation specialist to plan and execute risk-based validation of GxP computerised systems for pharmaceutical clients. You will prepare validation plans, URS reviews, risk assessments and run IQ/OQ/PQ protocols with summary reports.

The role requires strong technical writing, experience in GMP/GLP environments and the ability to support audits with validation evidence, manage deviations and changes, and work on client-site or remote validation projects.

Qualifications

• 4–9 years of CSV in pharma, biotech or a GxP service provider.
• Experience with GAMP 5 (2nd ed.), 21 CFR Part 11, EU Annex 11, ALCOA+.
• Ability to validate at least two of: LIMS, eQMS, DMS, ERP, MES, CDS.
• Strong technical writing skills.

Responsibilities

• Plan and execute risk-based validation of GxP computerised systems for pharmaceutical clients.
• Prepare validation plans, URS reviews and risk assessments
• Author and execute IQ/OQ/PQ protocols and summary reports
• Maintain requirements traceability through testing
• Manage deviations, change controls and periodic reviews
• Support audits with validation evidence

Skills

CSV experience

GAMP 5 / CFR Part 11 knowledge

Multi-system validation (LIMS / eQMS /

Strong technical writing

Job description

Plan and execute risk-based validation of GxP computerised systems for pharmaceutical clients.

• Prepare validation plans, URS reviews and risk assessments
• Author and execute IQ/OQ/PQ protocols and summary reports
• Maintain requirements traceability through testing
• Manage deviations, change controls and periodic reviews
• Support audits with validation evidence

Required skills

• 4–9 years of CSV in pharma, biotech or a GxP service provider
• GAMP 5 (2nd ed.), 21 CFR Part 11, EU Annex 11, ALCOA+
• Validation of at least two of: LIMS, eQMS, DMS, ERP, MES, CDS
• Strong technical writing

Preferred skills

• Computer Software Assurance (CSA) approach
• Validation tools (e.g. electronic test management)

Project / industry exposure

• Client-site and remote validation projects