Manufacturing IT Systems Specialist

Job Description

Qualifications

• High School or GED - Required
• Bachelor's Degree (BA / BS) Information Technology - Required
• 5 years or more in IT Experience or knowledge
• Clearly and effectively communicate with customers both in writing and verbally
• Maintains a high degree of professionalism while delivering outstanding Customer Service
• Advanced
• Work additional hours per business needs
• 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
• 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

Responsibilities

• 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
• Contribute in New Systems Selection and Implementation Collaborate with teams across Manufacturing, Supply Chain, Warehousing, Facilities, Validation Engineering, QA, and QM to document user requirements for future state manufacturing processes
• such as e logbook, eBRM, Electronic inventory card) Contribute to business process and system design discussions, offering ideas for solutions and potential business process improvements
• Support the development and documentation of functional and technical aspects of integrations between various IT systems
• Assist in creating testing and validation plans, ensuring that all IT requirements are met through appropriate testing regimes
• Maintenance and Support for Existing Manufacturing IT Systems
• Support the life cycle management of assigned production / manufacturing IT Collaborate with offshore team members for platform Help maintain system documentation for critical IT systems and support compliance with GxP Assist in incident and problem resolution using Lean methodology and support the continuous improvement of system usage and satisfaction
• Support Operation of Track and Trace Serialization Systems
• Assist in resolving technical and compliance issues related to serialization Provide support for packaging and labeling initiatives, ensuring compliance with global Support the technical operations of ACG / Systech Serialization and RfXcel systems and enable new partner and product setups in relevant IT systems
• Desktop Support and IT Troubleshooting
• Provide technical assistance and support for incoming queries and issues related to computer systems, Desk phones, Cellphones, Printers, software, and Address ServiceNow tickets through direct personal interaction or via telephone Write training manuals and train computer users as Install, modify, and repair computer hardware and software, ensuring minimal Run diagnostic programs to resolve problems and optimize performance
• 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

Qualifications

• High School or GED - Required
• Bachelor's Degree (BA / BS) Information Technology - Required
• 5 years or more in IT Experience or knowledge
• Clearly and effectively communicate with customers both in writing and verbally
• Maintains a high degree of professionalism while delivering outstanding Customer Service
• Advanced
• Work additional hours per business needs
• 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
• 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

Responsibilities

• 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
• Contribute in New Systems Selection and Implementation Collaborate with teams across Manufacturing, Supply Chain, Warehousing, Facilities, Validation Engineering, QA, and QM to document user requirements for future state manufacturing processes
• such as e logbook, eBRM, Electronic inventory card) Contribute to business process and system design discussions, offering ideas for solutions and potential business process improvements
• Support the development and documentation of functional and technical aspects of integrations between various IT systems
• Assist in creating testing and validation plans, ensuring that all IT requirements are met through appropriate testing regimes
• Maintenance and Support for Existing Manufacturing IT Systems
• Support the life cycle management of assigned production / manufacturing IT Collaborate with offshore team members for platform Help maintain system documentation for critical IT systems and support compliance with GxP Assist in incident and problem resolution using Lean methodology and support the continuous improvement of system usage and satisfaction
• Support Operation of Track and Trace Serialization Systems
• Assist in resolving technical and compliance issues related to serialization Provide support for packaging and labeling initiatives, ensuring compliance with global Support the technical operations of ACG / Systech Serialization and RfXcel systems and enable new partner and product setups in relevant IT systems
• Desktop Support and IT Troubleshooting
• Provide technical assistance and support for incoming queries and issues related to computer systems, Desk phones, Cellphones, Printers, software, and Address ServiceNow tickets through direct personal interaction or via telephone Write training manuals and train computer users as Install, modify, and repair computer hardware and software, ensuring minimal Run diagnostic programs to resolve problems and optimize performance
• 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