Manufacturing IT Systems Specialist

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 90,000 - 140,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Manufacturing IT Systems Specialist to support shop-floor manufacturing systems and the desktop computing environment. The role involves implementing and maintaining technology solutions, collaborating across departments, and ensuring high IT support standards.

You will work on serialization standards, DSCSA and FMD compliance, and integrate serialization with ERP/MES systems while leveraging data analytics tools for operational insights.

Qualifications

• Experience in serialization standards and compliance (GS1, DSCSA, FMD).
• Familiarity with DSCSA in the US and FMD in the EU.
• Ability to document and ensure regulatory compliance.
• Proficiency with serialization software and ERP/MES integrations.
• Knowledge of RFID and barcode systems in serialization workflows.
• Experience with API (XML, SOAP), AS2, and SFTP data integrations.

Responsibilities

• Support manufacturing systems and desktop computing environments on the shop floor.
• Collaborate with various departments to understand IT needs and drive improvements.
• Provide desktop and shop-floor IT support to ensure smooth daily operations.
• Address ServiceNow tickets via direct interaction or phone support.
• Write training materials and train users as needed.
• Install, modify, and repair hardware and software to minimize downtime.
• Run diagnostics to resolve problems and optimize performance.

Skills

Python

R

SQL

APIs integration

Traceability

PAT

IIT

Tools

ACG

Tradelink

rfxcel

Antares Vision

Systech

Optel

Oracle JDE

SAP ATTP

Rockwell MES

Werum PAS-X

RFID

Barcode systems

XML/SOAP API

AS2

SFTP

Tableau

PowerBI

QlikView

Job description

Manufacturing IT Systems Specialist

Support both the manufacturing systems and the desktop computing environment. This role involves assisting in the implementation and maintenance of technology solutions at the manufacturing shop‑floor level and providing desktop support to ensure seamless daily operations. The individual will collaborate with various departments to understand and meet their IT needs, contribute to system improvements, and maintain high standards of IT support and operational efficiency.

Track and Trace Technology, Serialization Standards and Compliance

• Deep knowledge of global serialization standards such as GS1.
• Familiarity with regulatory requirements like DSCSA (Drug Supply Chain Security Act) in the US, and the FMD (Falsified Medicines Directive) in the EU.
• Ability to ensure and document compliance with these standards and regulations.
• Proficiency with serialization software such as ACG, Tradelink, rfxcel, Antares Vision, Systech, or Optel.
• Experience with integrating serialization systems into enterprise systems like ERP (Oracle – JDE, SAP ATTP) and MES (Rockwell, Werum PAS‑X).
• Knowledge of RFID, barcode generation and scanning systems, and their integration with serialization systems.
• Understanding of how to implement and manage end‑to‑end traceability within the supply chain.

Data Integration via API, AS2, SFTP

• Experience with data integration via API (XML, SOAP), AS2, and SFTP.
• Data analytics and advanced automation expertise.

Data Analytics Tools

• Proficiency in data analytics tools (Python, R, SQL) for analyzing serialization and operational data.
• Experience with business intelligence tools like Tableau, PowerBI, or QlikView for creating dashboards and reports.

Process Analytical Technology (PAT) and Intelligent Instrumentation Technologies (IIT)

• Familiarity with PAT tools and techniques for real‑time process monitoring and control.
• Ability to integrate PAT into manufacturing operations to enhance quality and efficiency.
• Expertise in IIT technologies for real‑time monitoring, predictive maintenance, and process optimization.
• Ability to design and implement solutions within pharmaceutical manufacturing.
• Understanding of digital twin technology for simulating and optimizing manufacturing processes.
• Ability to create and manage digital twins for process validation and continuous improvement.

Shopfloor Support and IT Troubleshooting

• Provide technical assistance and support for incoming queries and issues related to computer systems, desk phones, cell phones, printers, software, and hardware.
• Address ServiceNow tickets through direct personal interaction or via telephone communication.
• Write training manuals and train computer users, as necessary.
• Install, modify, and repair computer hardware and software, ensuring minimal downtime.
• Run diagnostic programs to resolve problems and optimize performance.