Description:

The Manufacturing Shopfloor IT Specialist will be responsible for supporting IT systems related to manufacturing operations, ensuring compliance with regulatory standards, and troubleshooting technical issues. This role requires expertise in track and trace technology, serialization compliance, data analytics, and automation. The specialist will also provide desktop support and IT troubleshooting to enhance operational efficiency across the shop floor.

Essential Functions:

• 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. 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 (XML, SOAP), AS2, SFTP

• Data Analytics and Advanced automation expertise. Proficiency in data analytics tools (Python, R, SQL) for analyzing serialization and operational data.

• Experience with business intelligence tools like Tableau, Power BI, or QlikView for creating dashboards and reports.

• 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 IIoT technologies for real-time monitoring, predictive maintenance, and process optimization.

• Ability to design and implement IIoT 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, Cellphones, 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.

Additional Responsibilities:

• Learns fundamental operations of commonly used software, hardware, and other equipment.

• Adheres to all confidentiality rules and policies.

• Follow all company and department policies and rules.

• Ensures that all problems are logged, resolved/assigned for resolution, prioritized and tracked, and communicated appropriately.

• Other duties as assigned.

• Provides support to the Laboratory Environment with IT related requests; Protocol execution for the Laboratory computers and software