Job Description
Location: Bangalore (Peenya)
Role Overview:
We are looking for a CSV IT Engineer with hands-on experience in Computer System Validation and IT support for GxP systems in a regulated pharmaceutical environment.
Key Responsibilities:
Provide day-to-day IT support for:
• Windows OS, servers, and business applications
• User access management, roles, passwords, audit trails
• Incident resolution, root cause analysis, and documentation
• • Support system upgrades, patches, and migrations with validation impact assessment
• • Manage change control, deviations, periodic reviews for validated systems
• • Coordinate with QA, QC, IT teams, and vendors
• • Support regulatory and internal audits
Other Skill
• Execute CSV activities as per GAMP 5, 21 CFR Part 11, EU Annex 11
• Prepare & execute URS, RA, IQ, OQ, PQ, RTM, VSR
• Validate and support GxP systems (LIMS, QMS, ERP/SAP, Lab & Manufacturing systems)
Required Experience & Skills:
• Min 4– 5 years experience in CSV and regulated IT support
• Strong understanding of Data Integrity (ALCOA+)
• Experience working in pharma plant / GxP environment
• Good documentation, troubleshooting, and communication skills
• Immediate joiner preferred
🎓 Qualification: BE / BTech / BSc / MSc (IT / Computer or equivalent)
shailendra.bochkari@afdil.com
Role Overview:
We are looking for a CSV IT Engineer with hands-on experience in Computer System Validation and IT support for GxP systems in a regulated pharmaceutical environment.
Key Responsibilities:
Provide day-to-day IT support for:
• Windows OS, servers, and business applications
• User access management, roles, passwords, audit trails
• Incident resolution, root cause analysis, and documentation
• • Support system upgrades, patches, and migrations with validation impact assessment
• • Manage change control, deviations, periodic reviews for validated systems
• • Coordinate with QA, QC, IT teams, and vendors
• • Support regulatory and internal audits
Other Skill
• Execute CSV activities as per GAMP 5, 21 CFR Part 11, EU Annex 11
• Prepare & execute URS, RA, IQ, OQ, PQ, RTM, VSR
• Validate and support GxP systems (LIMS, QMS, ERP/SAP, Lab & Manufacturing systems)
Required Experience & Skills:
• Min 4– 5 years experience in CSV and regulated IT support
• Strong understanding of Data Integrity (ALCOA+)
• Experience working in pharma plant / GxP environment
• Good documentation, troubleshooting, and communication skills
• Immediate joiner preferred
🎓 Qualification: BE / BTech / BSc / MSc (IT / Computer or equivalent)
shailendra.bochkari@afdil.com
💡 Quick Summary
Seeking a career-building opportunity? The Information Technology Engineering Expert position is now open for candidates interested in the IT Engineer & Developer Jobs sector. This role in Mumbai offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in IT Engineer & Developer Jobs is a plus.