Plant IT – Pharma

18 hours ago

bangalore, India VRR Life Sciences Full time

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.

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