Plant IT – Pharma

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:

• Bachelors degree in computer science, Information Technology, Engineering, or a related field.
• 37 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.