Computer System Validation (CSV) Consultant / CSV Lead

Vaisesika; Nashik District; On-site; INR 2,000,000 - 3,500,000; Full time

Job summary

Vaisesika in Nashik is seeking an experienced Computer System Validation (CSV) professional with strong exposure to laboratory, manufacturing, packaging, and quality systems in a regulated Life Sciences/GxP environment. The role focuses on CSV gap assessments, remediation, validation lifecycle execution, documentation, testing, and audit readiness.

You will lead end-to-end CSV activities across LIMS, ELN, CDS, MES, serialization, SCADA, PLC/HMI, batch records, packaging and equipment interfaces,

Qualifications

• 6–16 years of hands-on CSV experience in Pharmaceutical, Biotechnology, Medical Device, Diagnostics, or regulated Life Sciences environments.
• Strong experience with CSV lifecycle, risk-based validation, testing, gap assessment, remediation, and validation documentation.
• Hands-on exposure to Laboratory, Manufacturing, Packaging, or Shopfloor systems.
• Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, Data Integrity, Audit Trails, Electronic Records & Electronic Signatures.
• Strong documentation and review experience across URS, RA, IQ, OQ, PQ, RTM, VSR, SOPs, and Periodic Reviews.
• Strong stakeholder coordination skills across Quality, IT, Business, Vendors, and System Owners.

Responsibilities

• Perform CSV gap assessments for laboratory, manufacturing, packaging, and shopfloor systems against GxP, regulatory, and internal quality requirements.
• Execute remediation plans for validation, documentation, compliance, and data integrity gaps.
• Lead/support the end-to-end CSV lifecycle, including validation planning, risk assessments, requirements review, test strategy, protocol development, execution, traceability, deviations, and validation summary.
• Prepare/review URS, FRS, Risk Assessments, IQ/OQ/PQ, RTM, test scripts, deviation reports, VSRs, SOPs, and periodic review documents.
• Support validation of LIMS, ELN, CDS, MES, serialization, SCADA, PLC/HMI, batch records, packaging systems, equipment interfaces, automation, and data acquisition systems.
• Collaborate with Quality, IT, Manufacturing, Packaging, Laboratory, Engineering, Automation, Business SMEs, vendors, and system owners.
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, audit trails, electronic records/signatures, and data integrity requirements.
• Review system changes, deviations, incidents, CAPAs, and periodic reviews from a CSV/compliance perspective.
• Ensure CSV documentation is complete, accurate, traceable, and audit/inspection ready.

Skills

CSV lifecycle

Risk-based validation

Testing

Gap assessment

Documentation

Stakeholder coordination

GxP compliance

Quality systems

Tools

LIMS

ELN

LabWare

EMPOWER

TrackWise

Veeva

Job description

Computer System Validation (CSV) Professional

Location: Nashik

Work Mode: Work from Office – 5 Days

Experience: 6–16 Years

Industry: Pharmaceutical / Biotechnology / Medical Devices / Diagnostics / Life Sciences

Role: Computer System Validation (CSV)

About the Role

We are looking for an experienced Computer System Validation (CSV) professional with strong exposure to Laboratory, Manufacturing, Packaging, and Quality systems in a regulated Life Sciences / GxP environment.

The role involves CSV gap assessments, remediation, validation lifecycle execution, documentation, testing, and audit readiness for computerized systems.

Key Responsibilities

• Perform CSV gap assessments for laboratory, manufacturing, packaging, and shopfloor systems against GxP, regulatory, and internal quality requirements.
• Execute remediation plans for validation, documentation, compliance, and data integrity gaps.
• Lead/support the end-to-end CSV lifecycle, including validation planning, risk assessments, requirements review, test strategy, protocol development, execution, traceability, deviations, and validation summary.
• Prepare/review URS, FRS, Risk Assessments, IQ/OQ/PQ, RTM, test scripts, deviation reports, VSRs, SOPs, and periodic review documents.
• Support validation of LIMS, ELN, CDS, MES, serialization, SCADA, PLC/HMI, batch records, packaging systems, equipment interfaces, automation, and data acquisition systems.
• Collaborate with Quality, IT, Manufacturing, Packaging, Laboratory, Engineering, Automation, Business SMEs, vendors, and system owners.
• Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, audit trails, electronic records/signatures, and data integrity requirements.
• Review system changes, deviations, incidents, CAPAs, and periodic reviews from a CSV/compliance perspective.
• Ensure CSV documentation is complete, accurate, traceable, and audit/inspection ready.

Required Skills & Experience

• 6–16 years of hands-on CSV experience in Pharmaceutical, Biotechnology, Medical Device, Diagnostics, or regulated Life Sciences environments.
• Strong experience with CSV lifecycle, risk-based validation, testing, gap assessment, remediation, and validation documentation.
• Hands-on exposure to Laboratory, Manufacturing, Packaging, or Shopfloor systems.
• Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, Data Integrity, Audit Trails, Electronic Records & Electronic Signatures.
• Strong documentation and review experience across URS, RA, IQ, OQ, PQ, RTM, VSR, SOPs, and Periodic Reviews.
• Strong stakeholder coordination skills across Quality, IT, Business, Vendors, and System Owners.

Preferred System Exposure

Laboratory: LIMS, ELN, CDS, Empower, LabWare, Chromeleon, MODA, Analytical Instrument Software

Manufacturing / Packaging: MES, Serialization, SCADA, PLC/HMI, Batch Record Systems, Packaging Line Systems, ERP Interfaces, Equipment Control Systems, Automation Platforms

Quality Systems: TrackWise, Veeva, MasterControl, ValGenesis, ServiceNow, Document Management Systems