Computer System Validation Engineer

Emcure Pharmaceuticals Limited; Mhalunge; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Emcure Pharmaceuticals Limited in India seeks a CSV specialist to manage and execute validation activities for GMP-regulated equipment and computerized systems across tablet, capsule, and PFS facilities.

The role focuses on ensuring compliance with GAMP 5, 21 CFR 11, data integrity, MHRA and WHO GMP standards, coordinating with QA and Engineering teams to support audits and inspections.

Qualifications

• Experience in CSV for GMP-regulated equipment and systems.
• Knowledge of GAMP 5 and data integrity principles.
• Ability to coordinate with QA, IT, Engineering and production teams.

Responsibilities

• Prepare and execute CSV lifecycle documents.
• Validate new systems, upgrades, and automation.
• Manage change controls and lifecycle documentation.
• Support audits and regulatory inspections.
• Coordinate with cross-functional teams.

Skills

CSV lifecycle

Regulatory compliance

GAMP 5

21 CFR Part 11

QA collaboration

Documentation

Tools

Validation software

PLC/SCADA

Job description

Manage and execute Computer System Validation (CSV) activities for GMP-regulated equipment, utilities, automation, and computerized systems across Tablet, Capsule, and PFS facilities, ensuring compliance with GAMP 5, 21 CFR Part 11, Data Integrity, EU GMP, MHRA, and WHO GMP requirements.

Key Responsibilities:

• Prepare and execute CSV lifecycle documents (URS, FS, DQ, FAT, SAT, IQ, OQ, PQ, VSR, VMP).
• Validate new computerized systems, equipment upgrades, software changes, and automation/SCADA systems.
• Conduct periodic reviews, compliance assessments, and revalidation activities.
• Manage change controls, impact assessments, and lifecycle documentation.
• Ensure regulatory compliance and support audits/inspections.
• Maintain validation records and coordinate with QA for approvals.
• Collaborate with Engineering, QA, IT, Production, Automation, and Project teams.

Systems Exposure: PLC/SCADA, BMS, HVAC, Water Systems, MES, EMS, Track & Trace, Laboratory Systems, PFS Equipment, Compression, Capsule Filling, Coating, and Packaging Lines.