Manufacturing IT Systems Specialist (Biotech)

Description:

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.

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.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 expertiseo 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.
• Shopfloor 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.

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

 

Education:

• High School or GED - Required
• Bachelors Degree (BA/BS) Information Technology - Required
• Master Degree (MS/MA) Information Technology - Preferred

Experience:

• 5 years or more in IT Experience or knowledge

Skills:

• Clearly and effectively communicate with customers both in writing and verbally. - Intermediate
• Maintains a high degree of professionalism while delivering outstanding Customer Service. - Advanced
• Work additional hours per business needs. - Intermediate
• Attends work regularly and on time. - Advanced
• Must be available over the company provided phone during off-hours - Advanced
• Knowledge of 21CFR Part 11, Data Integrity, Good Manufacturing Practices (cGMP), Good Documentation Practices (cGDP) and other regulatory requirements - Intermediate

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.
• Excellent understanding of both hardware and software systems

Licenses:

• Microsoft certificate for Windows --Preferred

 

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.