Manufacturing IT Manager

Role Summary

The 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.

Responsibilities

• Manufacturing Systems & Shop-Floor Technology
• Own and manage key manufacturing systems such as MES, ERP, LIMS, QMS, data historians, SCADA/ DCS systems, and shop-floor interfaces.
• Provide machine-level line support for production and packaging equipment, including HMIs, scanners, printers, weigh scales, robotics, vision systems, batch controllers, and line integration technology.
• Manage equipment connectivity, automation interface issues, and real-time troubleshooting on the production floor.
• Serialization & Track-and-Trace Management
• Lead IT oversight for Serialization systems across all packaging lines.
• Manage 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 systems.
• Ensure compliance with DSCSA, EU FMD, and other global serialization regulations.
• Coordinate with Quality and Supply Chain for audit readiness and traceability.
• GMP Compliance, CSV & Data Integrity
• Uphold GMP, cGMP, and GAMP 5 standards across all manufacturing and lab systems.
• Lead Computer System Validation (CSV) activities including URS, FS, DS, IQ/OQ/PQ, periodic reviews, and change control.
• Maintain ALCOA+ principles for data integrity and electronic record management.
• Ensure all systems comply with 21 CFR Part 11, Annex 11, and established pharma QC/QA processes
• Cross-Functional Leadership & Stakeholder Partnership
• Serve as the primary IT partner for Production, Packaging, Quality, QC Labs, Warehouse, Engineering, Maintenance, EHS, and Supply Chain.
• Run prioritization forums, change control boards, and business engagement reviews.
• Translate operational needs into digital roadmaps and practical solutions.
• Digital Transformation & Continuous Improvement
• Drive 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 systems.
• Lead vendor management, contracts, service agreements, and performance reviews.
• Infrastructure, Cybersecurity & OT Environment
• Oversee plant networks, servers, manufacturing VLANs, and segregated OT environments in partnerships with Network and Security Teams.
• Ensure cybersecurity compliance for connected manufacturing equipment, SCADA systems, and serialization infrastructure.
• Align with corporate IT on patching, backups, DR, and user access governance.
• Operational Support & Incident Management
• Provide real-time support for batch execution, packaging operations, serialization events, and lab workflows.
• Lead troubleshooting during downtime, deviations, and equipment-system integration failures.
• Maintain a structured on-call rotation model for 24/7 support.
• Team Leadership & Development
• Lead a team of shop-floor IT analysts, automation support engineers, and system administrators.
• Develop capabilities in GMP systems, shop-floor automation, integration, and validation.
• Foster a culture of compliance, urgency, and continuous improvement.

Skills

• Hands-on expertise in:
• Understanding of DSCSA, EU FMD, and global track-and-trace frameworks.
• Serialization technologies ( Optel, Tracelink)
• Packaging line automation (vision systems, scanners, printers, PLC/SCADA)
• MES (e.g., Werum PAS-X, Mater controls), ERP (SAP/Oracle), LIMS/QMS
• Computer System Validation (CSV), GAMP 5, cGMP, and data integrity
• Strong troubleshooting skills at machine, network, and application level.
• Excellent communication, leadership, and vendor management capabilities.

Qualifications

• 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 manufacturing.
• 5+ years of experience in pharmaceutical serialization, Tracelink, or EPCIS-based systems
• Less than 25% Travel (Baudette, EW)