Manufacturing IT Manager

About the Role

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

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

Requirements

• 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).

Compensation

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. Only to be included if position is STI and/or LTI bonus eligible: 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.

Benefits

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
• Paid time off
• Many of these benefits are subsidized or fully paid for by the company.