IT Support Engineer

Biogenomics; Puducherry; On-site; INR 900,000 - 1,200,000; Full time

Job summary

BioGenomics Limited in Puducherry seeks an experienced IT professional to provide day-to-day support for GMP and non-GMP systems, ensuring compliance with 21 CFR Part 11 and EU Annex 11. You will manage validated systems (LIMS, MES, ERP, BMS), implement CSV activities, and uphold data integrity in a highly regulated life sciences environment.

The role covers infrastructure, user access, incident management, and QA-aligned documentation, contributing to robust disaster recovery and change control

Qualifications

• Bachelor's degree in Information Technology, Computer Science, or a related field.
• 25 years of IT support experience in regulated life sciences environment.
• Hands-on with Windows Server, Active Directory, and networking fundamentals (TCP/IP, DNS, DHCP).
• Familiarity with GMP regulations EU Annex 11, 21 CFR Part 11, and GAMP 5 is advantageous.
• Experience supporting validated systems (LIMS, MES, ERP, BMS) preferred.
• Knowledge of data integrity principles (ALCOA+) in GMP context.

Responsibilities

• Provide day-to-day IT support for GMP and non-GMP systems (servers, workstations, network infra, validated apps).
• Ensure compliance with 21 CFR Part 11, EU Annex 11, and GMP data integrity guidelines.
• Maintain backup and disaster recovery procedures with periodic testing and evidence.
• Manage user accounts, access controls, and reviews across validated systems.
• Support CSV activities including IQ/OQ/PQ execution and documentation.
• Monitor LAN/WAN network, switches, firewalls, and wireless infrastructure.
• Manage on-site servers, storage, and UPS/power management.
• Patch management and antivirus updates per change control procedures.
• Maintain IT asset inventory and network architecture documentation.
• Act as first point of contact for IT incidents; log, track, close within SLAs.
• Provide hands-on support for hardware and software issues; train end users on GMP-compliant usage.
• Raise and manage deviations, change controls, and CAPAs per site quality system.
• Maintain SOPs, work instructions, and qualification docs with revision control.
• Support internal audits and regulatory inspections with IT documentation and access records.
• Ensure periodic audit trail reviews as required by site procedures.
• Coordinate with IT hardware/software vendors; manage asset lifecycle and licenses.

Skills

IT support

GMP compliance

CSV

Windows Server

Active Directory

Networking basics

LIMS

MES

ERP

BMS/EMS

Data integrity

Education

Bachelor's degree in Information Technology or Computer Science

Tools

LIMS

MES

ERP

BMS

Job description

BioGenomics Limited

Location: Puducherry

https://biogenomics.co.in/

Key Responsibilities -IT- Puducherry

GMPITOperations

• Provide day-to-dayITsupport for all GMP and non-GMP systems including servers, workstations, network infrastructure, and validated applications (LIMS, MES, ERP, BMS/EMS)
• Ensure allITactivities at the facility comply with 21 CFR Part 11, EU Annex 11, and applicable GMP data integrity guidelines
• Maintain and execute the facility's backup and disaster recovery procedures; perform periodic restoration testing and document evidence
• Manage user accounts, role-based access controls, and periodic access reviews across all validated systems
• Support and participate in CSV (Computer System Validation) activities including IQ/OQ/PQ execution, generating test evidence, and maintaining validation documentation

Infrastructure & Network

• Monitor and maintain LAN/WAN network, switches, firewalls, and wireless infrastructure across the facility
• Manage on-site servers (physical and/or virtual), storage systems, and UPS/power management
• Ensure patch management and antivirus updates are carried out in a controlled, documented manner compliant with change control procedures
• Maintain network architecture documentation andITasset inventory

Helpdesk & End-User Support

• Act as the first point of contact (Level 1 & Level 2) for allIT-related incidents and service requests raised by facility staff
• Log, track, and close incidents within defined SLAs using the helpdesk/ticketing system
• Provide hands‑on support for hardware (desktops, laptops, printers, scanners, label printers) and software issues
• Train end users on GMP‑compliant system usage, password policies, and data integrity awareness

Compliance & Documentation

• Raise and manageIT‑related deviations, change controls, and CAPAs in line with the site quality management system
• MaintainITSOPs, work instructions, and qualification documents; ensure all documents are revision‑controlled
• Support internal audits, regulatory inspections, and mock inspections by providingITdocumentation and system access records on request
• Ensure audit trail reviews are conducted periodically and documented as required by site procedures

Vendor & Asset Management

• Coordinate withIThardware and software vendors for procurement, installation, and support activities
• ManageITasset lifecycle from procurement and tagging through to decommissioning and data sanitisation
• Maintain and renew software licences, AMC/support contracts, and warranty records

Qualifications & Experience

• Bachelor's degree in Information Technology, Computer Science, or a related field
• 25 years ofITsupport experience, preferably in a pharmaceutical, biotech, or regulated life sciences environment
• Hands‑on experience with Windows Server, Active Directory, and networking fundamentals (TCP/IP, DNS, DHCP, VLANs)
• Familiarity with GMP regulations EU Annex 11, 21 CFR Part 11, and GAMP 5 is a strong advantage
• Experience supporting validated systems (LIMS, MES, ERP, BMS) is preferred
• Knowledge of data integrity principles (ALCOA+) in a GMP context

Key Competencies

• Strong problem‑solving and fault‑diagnosis skills
• Ability to work in a highly regulated, documentation‑driven environment
• Attention to detail — especially in maintaining records, logs, and change control documentation
• Good communication skills; able to interface with QA, production, and external vendors
• Self‑driven and capable of managing priorities with minimal supervision — critical given the site's current resource constraints