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Plant IT – Pharma
4 weeks ago
Job Title: Plant IT – Pharma (GxP Compliance)Location: BangaloreDepartment: IT Operations / Manufacturing ITExperience: 1 - 6 yearsEmployment Type: Full-TimeJob 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.
