OT IT Manager

OT IT ManagerJob SummaryANI Pharmaceuticals is seeking an experienced Manufacturing IT Manager to lead and support manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. The role focuses on manufacturing systems, serialization, automation, compliance, digital transformation, and operational technology (OT) across production, packaging, quality, supply chain, and lab operations.Key ResponsibilitiesManage Manufacturing IT systems including MES, ERP, LIMS, QMS, SCADA/DCS, and Data Historians.Provide shop-floor and machine-level support for production and packaging equipment.Lead Serialization and Track & Trace initiatives using platforms such as TraceLink, Optel, Systech, and Antares.Ensure compliance with cGMP, GAMP 5, CSV, 21 CFR Part 11, Annex 11, and ALCOA+ standards.Support equipment integration, automation, packaging line technologies, and real-time troubleshooting.Drive digital transformation initiatives including paperless batch records, IoT, and smart manufacturing solutions.Oversee plant IT infrastructure, OT environments, cybersecurity, disaster recovery, and access governance.Partner with Production, Quality, Engineering, Supply Chain, and Regulatory teams to deliver operational excellence.Lead vendor management, system upgrades, migrations, and continuous improvement programs.Required SkillsManufacturing IT in a GMP-regulated pharmaceutical environmentSerialization Technologies (TraceLink, Optel, EPCIS)MES, ERP (SAP/Oracle), LIMS, QMSPackaging Line Automation, PLC/SCADA, Vision Systems, Scanners & PrintersComputer System Validation (CSV)cGMP, GAMP 5, Data Integrity, 21 CFR Part 11DSCSA, EU FMD, and Global Track-and-Trace ComplianceInfrastructure, OT Networks, CybersecurityStrong Leadership, Stakeholder Management, and Vendor Management