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 recent 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.

Role: Engineering - Other, Industry Type: Pharmaceutical & Life Sciences, Department: Production, Manufacturing & Engineering, Employment Type: Full Time, Permanent Role Category: Engineering Education UG: B.Tech / B.E. in Any Specialization PG: MS/M.Sc(Science) in Any Specialization read more

Key Skills Skills highlighted with ‘‘ are preferred keyskills CSVGampEquipment QualificationGMP & Regulatory Compliance 21 Cfr Part 11Data Integrity ComplianceRisk AssessmentPLC/SCADA ValidationChange Request Management

📌 Computer System Validation Engineer (Pune)
🏢 Emcure
📍 Pune