Job Description: IT Infrastructure, End User Support & Shopfloor IT / UAM 1. IT Infrastructure & End User Support • Provide Level-2 technical support by diagnosing and resolving hardware, software, network, and operating system issues. • Administer Windows Server environments, including patch management, performance optimization, security hardening, and routine maintenance. • Manage Active Directory, including user accounts, Group Policy Objects (GPOs), Organizational Units (OUs), security groups, and access controls. • Administer Microsoft 365 services and provide end-user support. • Maintain LAN/WAN, Wi-Fi, switches, and endpoint connectivity. • Deploy and administer Mobile Device Management (MDM) solutions. • Perform backup, restoration, disaster recovery, and storage administration activities. • Monitor IT infrastructure health and coordinate with OEMs and vendors for timely issue resolution. • Maintain IT asset inventory, software licenses, and related documentation. 2. User Access Management (UAM) & Shopfloor IT Support • Manage the complete User Access Management (UAM) lifecycle, including user creation, modification, periodic access reviews, suspension, deactivation, and access reconciliation for laboratory and production shopfloor computerized systems and equipment. • Coordinate access approvals with Business Owners, System Owners, Quality Assurance (QA), and Human Resources (HR), ensuring complete documentation and audit evidence. • Ensure timely access modification and deactivation for employees who are transferred, separated, or resigned. • Support UAM audits, investigations, deviations, Corrective and Preventive Actions (CAPA), and change controls. • Ensure compliance with approved procedures, access control matrices, and applicable GxP requirements. 3. Laboratory Shopfloor IT & UAM • Chromatography Data Systems (CDS): Manage UAM and IT support for systems such as Empower and Chromeleon, including user provisioning, role/profile management, access reviews, and access-related troubleshooting. • Non-CDS Laboratory Equipment: Provide UAM and IT support for standalone and network-connected laboratory instruments and associated software, including TOC, LBPC, FTIR, Malvern, Zetasizer, and other computerized laboratory equipment. • Laboratory Enterprise Applications: Manage user access and provide access-related support for LIMS, QMS/Caliber, TrackWise, and other applicable GxP laboratory and quality applications. • Coordinate with Laboratory, Quality, Engineering, Automation, and OEM/vendor teams to resolve system access and technical issues. • Maintain UAM records, access approval evidence, and supporting documentation in accordance with approved SOPs. 4. Production Shopfloor IT & UAM • Production Control & Automation Systems: Manage and support UAM activities for SCADA, PLC, HMI, and related production equipment and application interfaces, including user provisioning, role management, access modification, deactivation, and periodic access reviews. • Provide IT support for electronic logbooks (eLogs) and other production shopfloor computerized applications. • Provide hands-on technical support during equipment and system breakdowns, coordinating with Engineering, Automation, OEM/vendor teams, and other cross-functional teams (CFTs) for timely resolution. • Perform and coordinate backup, restoration, and recovery activities for applicable production shopfloor computerized systems and equipment. • Monitor and verify time synchronization of applicable production systems and equipment against approved time sources. • Execute and coordinate operating system (OS) hardening, security configuration, patch management, and vulnerability remediation for production shopfloor computerized equipment, considering validated-system and GxP requirements. • Maintain complete documentation and audit evidence for UAM, backup and restoration, time synchronization, OS hardening, breakdown support, and other GxP IT activities. • Ensure continuous shopfloor IT operational readiness and support compliance with GMP, GAMP 5, 21 CFR Part 11, EU GMP Annex 11, ALCOA+, and Data Integrity requirements. 5. IT Compliance, CSV & Audit Support • Support internal, external, customer, and regulatory IT audits and inspections. • Ensure adherence to GMP, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, Data Integrity, and applicable cybersecurity requirements. • Support Computer System Validation (CSV) activities, including IQ/OQ/PQ documentation, risk assessments, and validation reports. • Execute IT change controls and maintain complete documentation and audit evidence. • Support deviation investigations, CAPA implementation, and closure, ensuring timely resolution of identified gaps. • Maintain continuous audit readiness across laboratory and production shopfloor IT systems. 6. Information Security & Cybersecurity • Support endpoint security, vulnerability assessment and remediation, and security patch management. • Maintain approved security configurations and ensure compliance with IT security policies. • Support backup integrity, restoration testing, and disaster recovery readiness. • Monitor and address security risks associated with laboratory and production shopfloor computerized systems. • Coordinate with central IT and cybersecurity teams to implement security controls without compromising validated system functionality. 7. Required Technical Skills • Windows Server Administration and Active Directory. • Microsoft 365 Administration. • VMware/Hyper-V Virtualization. • LAN/WAN, Wi-Fi, Switching, and Network Troubleshooting. • Mobile Device Management (MDM). • Backup, Restoration, Storage Administration, and Disaster Recovery. • User Access Management (UAM) / Identity and Access Management (IAM). • Laboratory and Production Shopfloor Computerized Systems. • ServiceNow / IT Service Management. • Endpoint Security, OS Hardening, Patch Management, and Vulnerability Remediation. • Computer System Validation (CSV), Change Management, and IT Asset Management. 8. Regulatory & Compliance Knowledge • Good Manufacturing Practices (GMP). • GAMP 5. • 21 CFR Part 11. • EU GMP Annex 11. • ALCOA+ principles and Data Integrity. • GxP computerized system compliance. • IT security, audit readiness, and electronic records and electronic signatures requirements. 9. Educational Qualification Bachelor’s degree in Computer Engineering, Information Technology, Computer Science, Electronics, or a related discipline. 10. Experience • 5–8 years of experience in IT Infrastructure and End User Support. • Minimum 3 years of experience in a regulated pharmaceutical or life sciences environment. • Practical experience supporting laboratory and production shopfloor computerized systems in a GMP-regulated environment is preferred. 11. Behavioral Competencies • Strong analytical and troubleshooting skills. • Hands-on execution and a proactive approach to issue resolution. • Customer-focused mindset with a strong sense of ownership and accountability. • Excellent documentation, communication, and coordination skills. • Ability to work effectively with QA, Production, Laboratory, Engineering, Automation, and OEM/vendor teams. • Strong commitment to compliance, data integrity, cybersecurity, and continuous audit readiness. Education: • Bachelors Degree (BA/BS) B.Tech - Required • Master Degree (MS/MA) M.Tech - Preferred Experience: • 5 years or more in 5 - 8 Years Specialized Knowledge: Licenses: