Senior Executive, IT User Support

• Bachelors Degree (BA/BS) B.Tech - Required

• Master Degree (MS/MA) M.Tech - Preferred

• 5 years or more in 5 - 8 Years

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.

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

1. 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.

1. Educational Qualification

Bachelor’s degree in Computer Engineering, Information Technology, Computer Science, Electronics, or a related discipline.

1. 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.

1. 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.