L2 IT Plant Engineer

Job Description - L2 IT Engineer (Plant IT & User Access Management)
Purpose
The L2 IT Engineer is responsible for providing technical support, maintaining plant IT infrastructure, ensuring the availability and security of IT systems, and supporting pharmaceutical manufacturing & Laboratory operations in compliance with GMP, GxP, 21 CFR Part 11, Annex 11, and organisational policies. The role also includes User Access Management (UAM), IT compliance, audit readiness, and infrastructure projects.
IT Infrastructure & End User Support  Provide Level-2 technical support for end users by diagnosing and resolving hardware, software, network, and operating system issues.  Administer Windows Server environments, including patch management, performance optimization, and security hardening.  Manage Active Directory (users, GPOs, OUs, security groups, access control).  Administer Microsoft 365 services.  Maintain LAN/WAN, Wi-Fi, switches, and endpoint connectivity.  Deploy and administer MDM solutions.  Perform backup, restoration, disaster recovery, and storage administration.  Monitor infrastructure health and coordinate with OEMs/vendors.  Maintain IT asset inventory and software licensing.
User Access Management (UAM) & Shopfloor IT Support  Manage the complete UAM lifecycle, including user creation, modification, periodic access review, suspension, deactivation, and access reconciliation for Laboratory and Production Shopfloor systems/equipment.  Coordinate UAM approvals with respective Business Owners, System Owners, QA and HR, and maintain complete supporting documentation and audit evidence.  Ensure timely access modification/deactivation for transferred, separated, or resigned employees.  Support UAM-related audits, investigations, CAPAs, deviations, and change controls.
1. Laboratory Shopfloor IT & UAM  CDS Systems: Manage UAM and IT support for Chromatography Data Systems (CDS), including Empower and Chromeleon; support user creation/modification/deactivation, role/profile management, periodic access review, and access-related troubleshooting.  Non-CDS Laboratory Equipment: Manage UAM and IT support for standalone/network-connected laboratory equipment and associated software, including TOC, LBPC, FTIR, Malvern, Zetasizer, and other computerized laboratory instruments/equipment.  Laboratory Enterprise Applications: Manage UAM and access-related support for LIMS, QMS / Caliber, TrackWise, and other applicable GxP laboratory/quality applications.
2. Production Shopfloor IT & UAM  Production Control & Automation Systems: Manage/support UAM activities for SCADA, PLC, HMI, and related production equipment/application interfaces, including user provisioning, modification, deactivation, role/access management, and periodic access review.  Provide IT support for eLog / electronic logbook systems.  Provide IT support during equipment/system breakdowns and coordinate with Engineering, Automation, OEM/vendor, and other CFTs for timely resolution.  Perform/coordinate backup and restoration activities for applicable production shopfloor computerized systems/equipment.  Ensure and monitor time synchronization of applicable production systems/equipment with approved time sources.  Execute/coordinate OS hardening, security configuration, patching, and vulnerability remediation of Production Shopfloor computerized equipment, considering validated/GxP requirements.  Maintain required documentation/evidence for UAM, backup, time synchronization, OS hardening, breakdown support, and other GxP IT activities.  Support audit readiness and compliance with GMP, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, and Data Integrity requirements.
IT Compliance, CSV & Audit Support  Support internal, external, and regulatory IT audits.  Ensure compliance with GMP, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, and cybersecurity requirements.  Support CSV documentation (IQ/OQ/PQ, Risk Assessment, Validation Reports).  Execute IT Change Control and maintain audit evidence.  Support CAPA, deviation investigations, and inspection readiness. Information Security & Cybersecurity  Support endpoint security, vulnerability remediation, and security patching.  Maintain secure configurations and disaster recovery readiness.
Required Technical Skills  Windows Server, Active Directory, Microsoft 365, VMware/Hyper-V, LAN/WAN, MDM, Backup & DR, UAM/IAM, ServiceNow, Endpoint Security, CSV, Change Management, IT Asset Management.
Regulatory Knowledge  GMP, GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+, Data Integrity, IT Compliance. Educational Qualification  Bachelor's Degree in Computer Engineering, Information Technology, Computer Science, Electronics, or related field.
Experience  5-8 years in IT Infrastructure and End User Support.  Minimum 3 years in a regulated pharmaceutical/life sciences environment.
Behavioral Competencies  Analytical, customer-focused, accountable, strong documentation skills, effective communication, and teamwork

Work arrangement
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