Job Title : Plant IT – Pharma (GxP Compliance)
Location : Bangalore
Department : IT Operations / Manufacturing IT
Experience : 1 - 6 years
Employment Type : Full-Time
Job Summary :
We are seeking a skilled and proactive Plant IT Operations Specialist to support day-to-day IT operations at our manufacturing facility. The ideal candidate will have a solid background in IT systems and infrastructure, hands-on experience in plant-floor technologies, and a strong understanding of GxP compliance in a regulated (pharma / biotech / FMCG) environment.
Key Responsibilities :
- Provide on-site IT support for all plant-related hardware, software, and network systems.
- Manage and troubleshoot IT infrastructure including servers, switches, routers, and wireless networks.
- Ensure smooth functioning of production systems, including SCADA, MES, LIMS, DCS, PLCs, and other manufacturing systems.
- Support and maintain printers, barcode scanners, HMIs, and production-line IT equipment.
- Coordinate with global IT teams for service requests, incident management, and change control processes.
- Ensure all IT systems and processes comply with GxP standards, 21 CFR Part 11, Annex 11, and internal quality guidelines.
- Participate in CSV (Computer System Validation), system assessments, and periodic reviews of GxP systems.
- Maintain accurate documentation for validated systems including IQ, OQ, PQ protocols and SOPs.
- Support audits and inspections by providing documentation and explaining IT practices related to regulated systems.
- Work with cross-functional teams (engineering, QA, manufacturing) on system integration and digitalization initiatives.
- Participate in risk assessments and change control processes for plant IT systems.
- Ensure all plant IT systems comply with corporate cybersecurity policies and data integrity standards.
- Perform periodic backups, patching, antivirus monitoring, and disaster recovery drills.
- Maintain accurate inventory of IT assets and ensure adherence to lifecycle management procedures.
Required Qualifications :
Bachelor’s degree in computer science, Information Technology, Engineering, or a related field.3–7 years of experience in IT operations within a GxP-regulated manufacturing environment.Strong knowledge of GMP, GAMP 5, 21 CFR Part 11, and other compliance frameworks.Experience with MES, LIMS, SCADA / DCS systems, and plant automation tools.Hands-on experience with Windows OS, Active Directory, virtualization (VMware / Hyper-V), networking, and ITSM tools.Familiarity with ITIL practices, change management, and ticketing systems (e.g., ServiceNow, Remedy).Excellent communication and problem-solving skills; ability to work independently and in cross-functional teams.