Computer System Validation (CSV) Consultant / CSV Lead

Vaisesika; Nashik District; On-site; INR 1,600,000 - 2,100,000; Full time

Job summary

Vaisesika in Nashik is seeking an experienced CSV professional to lead validation lifecycle across laboratory, manufacturing, packaging and quality systems in a regulated Life Sciences environment.

This role requires 6–16 years of hands-on CSV experience and deep knowledge of GxP, 21 CFR Part 11, EU Annex 11, and data integrity. You will drive risk-based validation and ensure audit readiness across multiple systems.

Qualifications

• 6–16 years of hands-on CSV experience in life sciences environments.
• Exposure to CSV lifecycle, risk-based validation, testing, gap assessment, remediation, and documentation.
• Experience with Laboratory, Manufacturing, Packaging, or Shopfloor systems.
• Knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, ALCOA+, Data Integrity, Audit Trails, and Electronic Records.

Responsibilities

• Perform CSV gap assessments for lab, manufacturing, packaging, and shopfloor systems.
• Execute remediation plans for validation, documentation, compliance, and data integrity gaps.
• Lead 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 reviews.
• 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.

Skills

CSV lifecycle

Risk-based validation

Documentation & review

GxP compliance

Stakeholder coordination

Tools

LIMS

ELN

CDS

Empower

LabWare

SCADA

PQC/PLC/HMI

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