Manufacturing IT Manager

Princeton, NJ, United States and 1 more (Hybrid)Job DescriptionAbout the RoleThe Manufacturing IT Manager is responsible for overseeing all manufacturing and shop-floor IT systems within a GMP-regulated pharmaceutical environment. This role ensures uptime, compliance, and integration across Production, Packaging, Serialization, Quality, Engineering, Supply Chain, Labs, and EHS. The leader will support machine-level operations, drive digital transformation, and ensure strict adherence to GxP and data integrity requirements.Responsibilities1.Manufacturing Systems & Shop-Floor TechnologyOwn and manage key manufacturing systems such as MES, ERP, LIMS, QMS, data historians, SCADA/ DCS systems, and shop-floor interfacesProvide machine-level line support for production and packaging equipment, including HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technologyManage equipment connectivity, automation interface issues, and real-time troubleshooting on the production floor2. Serialization & Track-and-Trace ManagementLead IT oversight for Serialization systems across all packaging linesManage Level 2-4 serialization systems (e.g., Antares, Systech, Tracelink, Optel)Support aggregation systems, label printing solutions, vision inspection tools, handheld devices, and data exchanges with ERP and regulatory systemsEnsure compliance with DSCSA, EU FMD, and other global serialization regulationsCoordinate with Quality and Supply Chain for audit readiness and traceability3. GMP Compliance, CSV & Data IntegrityUphold GMP, cGMP, and GAMP 5 standards across all manufacturing and lab systemsLead Computer System Validation (CSV) activities including URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change controlMaintain ALCOA+ principles for data integrity and electronic record managementEnsure all systems comply with 21 CFR Part 11, Annex 11, and established pharma QC/QA processes4. Cross-Functional Leadership & Stakeholder PartnershipServe as the primary IT partner for Production, Packaging, Quality, QC Labs, Warehouse, Engineering, Maintenance, EHS, and Supply ChainRun prioritization forums, change control boards, and business engagement reviewsTranslate operational needs into digital roadmaps and practical solutions5. Digital Transformation & Continuous ImprovementDrive initiatives such as paperless batch records, digital logbooks, automated reporting, IoT sensors, and machine connectivity (Pharma 4.0)Manage upgrades, migrations, and integrations for manufacturing and packaging systemsLead vendor management, contracts, service agreements, and performance reviews6. Infrastructure, Cybersecurity & OT EnvironmentOversee plant networks, servers, manufacturing VLANs, and segregated OT environments in partnerships with Network and Security TeamsEnsure cybersecurity compliance for connected manufacturing equipment, SCADA systems, and serialization infrastructureAlign with corporate IT on patching, backups, DR, and user access governance7. Operational Support & Incident ManagementProvide real-time support for batch execution, packaging operations, serialization events, and lab workflowsLead troubleshooting during downtime, deviations, and equipment-system integration failuresMaintain a structured on-call rotation model for 24/7 support8. Team Leadership & DevelopmentLead a team of shop-floor IT analysts, automation support engineers, and system administratorsDevelop capabilities in GMP systems, shop-floor automation, integration, and validationFoster a culture of compliance, urgency, and continuous improvementSkillsHands-on expertise in:Understanding of DSCSA, EU FMD, and global track-and-trace frameworksSerialization technologies ( Optel, Tracelink)Packaging line automation (vision systems, scanners, printers, PLC/SCADA)MES (e.g., Werum PAS-X, Mater controls), ERP (SAP/Oracle), LIMS/QMSComputer System Validation (CSV), GAMP 5, cGMP, and data integrityStrong troubleshooting skills at machine, network, and application levelExcellent communication, leadership, and vendor management capabilitiesRequirements:Bachelor's degree in supply chain, IT, Regulatory Affairs, or Manufacturing , IT , Engineering. 8 years of IT experience with at least 5 years supporting GMP-regulated pharmaceutical manufacturing5+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systemsLess than 25% Travel (Baudette, EW)The base salary (hourly) range for this position is $120,000-$150,000; the exact salary depends on various factors such as experience, skills, education, location, competencies and industry-specific knowledge. In addition to base salary, this position is eligible for participation in a competitive short term (and long term) incentive program based on performance and company results. ANI Pharmaceuticals offers a variety of benefits to eligible employees, including health insurance coverage, life and disability insurance, retirement savings plans, paid leave programs, paid holidays and paid time off. Many of these benefits are subsidized or fully paid for by the company.