What are the responsibilities and job description for the Manufacturing IT Systems Specialist position at Amneal Pharmaceuticals of New York LLC?
The Manufacturing IT Systems Specialist will 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 o Deep knowledge of global serialization standards such as GS1. o Familiarity with regulatory requirements like DSCSA (Drug Supply Chain Security Act) in the US, and the FMD (Falsified Medicines Directive) in the EU. o Ability to ensure and document compliance with these standards and regulations. o Proficiency with serialization software such as ACG, Tradelink, rfxcel, Antares Vision, Systech, or Optel. o Experience with integrating serialization systems into enterprise systems like ERP (Oracle JDE, SAP ATTP) and MES (Rockwell, Werum PAS-X). o Knowledge of RFID, barcode generation and scanning systems, and their integration with serialization systems. o Understanding of how to implement and manage end-to-end traceability within the supply chain. o Data integration via API (XML, SOAP), AS2, SFTP Data Analytics and Advanced automation expertise o Proficiency in data analytics tools (Python, R, SQL) for analyzing serialization and operational data. o Experience with business intelligence tools like Tableau, Power BI, or QlikView for creating dashboards and reports. o Familiarity with PAT tools and techniques for real-time process monitoring and control. o Ability to integrate PAT into manufacturing operations to enhance quality and efficiency. o Expertise in IIoT technologies for real-time monitoring, predictive maintenance, and process optimization. o Ability to design and implement IIoT solutions within pharmaceutical manufacturing. o Understanding of digital twin technology for simulating and optimizing manufacturing processes. o Ability to create and manage digital twins for process validation and continuous improvement. Shop floor Support and IT Troubleshooting o Provide technical assistance and support for incoming queries and issues related to computer systems, Desk phones, Cellphones, Printers, software, and hardware. o Address ServiceNow tickets through direct personal interaction or via telephone communication. o Write training manuals and train computer users, as necessary. o Install, modify, and repair computer hardware and software, ensuring minimal downtime. o Run diagnostic programs to resolve problems and optimize performance.Education : Bachelors Degree (BA / BS) Information TechnologyRequired Experience : 5 years or more in IT Experience or knowledge 5 years or more experience in Pharmaceutical Manufacturing IT - requiredWork additional hours per business needs. Must be available over the company provided phone during off-hours Knowledge of 21CFR Part 11, Data Integrity, Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP) and other regulatory requirementsIntermediate Specialized Knowledge : Familiarity with systems like electronic logbooks, batch record management, and inventory management systems tailored to manufacturing processes. Understanding of Good Practices compliance in regulated industries such as pharmaceuticals, ensuring all activities adhere to legal standards.Knowledge of serialization technologies and systems for track and trace compliance, crucial for pharmaceutical packaging and distribution. Experience with service management tools like ServiceNow and skills in providing comprehensive support and maintenance for IT systems.Licenses : Microsoft certificate for Windows Preferred