Manufacturing IT Manager
Full-time
Pi-Square Technologies LLC
Manufacturing IT Manager
Job Summary
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We are looking for 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 Responsibilities- Manage 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.
- Manufacturing IT in a GMP-regulated pharmaceutical environment
- Serialization Technologies ( TraceLink, Optel, EPCIS )
- MES, ERP (SAP/Oracle), LIMS, QMS
- Packaging Line Automation, PLC/SCADA, Vision Systems, Scanners & Printers
- Computer System Validation (CSV)
- cGMP, GAMP 5, Data Integrity, 21 CFR Part 11
- DSCSA, EU FMD, and Global Track-and-Trace Compliance
- Infrastructure, OT Networks, Cybersecurity
- Strong Leadership, Stakeholder Management, and Vendor Management
Pi-square technologies is a Michigan (USA) Headquartered Automotive Embedded Engineering Services company, Synergy Partner for major OEMs and Tier 1s and their implementation partners in Automotive Embedded Product Development, Projects, Requirements Analysis, Software Design, Software Implementation, Efficient Build, Release Process, and turnkey software V & V Services. We have more than 20+ years of industry expertise with specialization in the latest cutting-edge automotive technologies such as Infotainment, connected vehicles, Cyber security, OTA, and Advanced Safety/ Body electronics.
Vacancy posted 2 days ago
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