AUTOMATION AND INFORMATION TECHNOLOGY (IT) SYSTEMS

The head of Automation and IT provides technical leadership and expertise for automation systems to support manufacturing operations in accordance with appropriate Good Manufacturing Practices (GMP). He/she will develop or insource manufacturing execution systems for process control, change control implementation, deviation investigation, testing and supply chain management. He/she will also establish information technology systems for batch control, release, and inventory management. This role provides information technology solutions to scale up production and business operations. He/she will evaluate and implement automation control strategies for new or improved processes developed for pharmaceutical manufacturing operations.

• Program and configure automation systems, including but not limited to Distributed Control Systems (DCS), Manufacturing execution systems (MES), and Inventory Management
• Create, validate, and manage automation related change controls
• Design and implement automation changes to the manufacturing process.
• Investigate automation related deviations and other deviations.
• Provide technical support for automation control system platforms and/or process information systems (e.g., data historians).
• Execute all work in a manner consistent with GMP, regulatory, and ISO standards.
• Perform data mining and analysis to monitor the performance and identify improvements in the manufacturing process.
• Perform automation computer system support activities (e.g., system backups, performance monitoring, password maintenance, etc.)

• Degree in Computer Science, Electronic Engineering, or qualifications in another relevant discipline with 10 plus years’ experience in Biologics/Biotech manufacturing environment.