BioGenomics Limited

Location: Puducherry https://biogenomics.co.in/

Key Responsibilities - IT - Puducherry

GMP IT Operations

- Provide day-to-day IT support for all GMP and non-GMP systems including servers, workstations, network infrastructure, and validated applications (LIMS, MES, ERP, BMS/EMS)
- Ensure all IT activities 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 and IT asset inventory

Helpdesk & End-User Support

- Act as the first point of contact (Level 1 & Level 2) for all IT-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 manage IT-related deviations,



change controls, and CAPAs in line with the site quality management system
- Maintain IT SOPs, work instructions, and qualification documents; ensure all documents are revision-controlled
- Support internal audits, regulatory inspections, and mock inspections by providing IT documentation and system access records on request
- Ensure audit trail reviews are conducted periodically and documented as required by site procedures

Vendor & Asset Management

- Coordinate with IT hardware and software vendors for procurement, installation, and support activities
- Manage IT asset 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 of IT support 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

- Robust 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

📌 IT Support Engineer (Puducherry)
🏢 BioGenomics
📍 Puducherry