OT IT Manager

Pi Square Technologies; Minnesota; On-site; USD 120,000 - 170,000; Full time

Job summary

ANI 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 OT across production, packaging, quality, supply chain, and lab operations. You will partner with cross-functional teams to deliver operational excellence and ongoing system upgrades.

Qualifications

• Manufacturing IT experience in a GMP-regulated pharma environment.
• Experience with MES, ERP (SAP/Oracle), LIMS, QMS.

Responsibilities

• Lead Manufacturing IT systems (MES, ERP, LIMS, QMS, SCADA/DCS, Data Historians).
• Provide shop-floor and machine-level support for production equipment.
• Lead serialization and track & trace initiatives (TraceLink, Optel, Systech, Antares).
• Ensure compliance with cGMP, GAMP 5, CSV, 21 CFR Part 11, Annex 11, and ALCOA+.

Skills

Manufacturing IT

MES

ERP (SAP/Oracle)

LIMS

QMS

Packaging automation

PLC/SCADA

Vision systems

Scanners & printers

CSV

cGMP

GAMP 5

Data integrity

21 CFR Part 11

DSCSA EU FMD

OT networks

Cybersecurity

Leadership

Vendor management

Job description

ANI 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 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.

Required Skills

• Manufacturing IT in a GMP-regulated pharmaceutical environment
• 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