AUTOMATION AND INFORMATION TECHNOLOGY (IT) SYSTEMS

About the role

Provides technical leadership and expertise for automation systems to support manufacturing operations in accordance with Good Manufacturing Practices (GMP). Develops or insources manufacturing execution systems for process control, change control implementation, deviation investigation, testing, and supply chain management. Establishes information technology systems for batch control, release, and inventory management, scaling up production and business operations. Evaluates and implements automation control strategies for new or improved processes in pharmaceutical manufacturing.

Responsibilities

• Program and configure automation systems, including 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 performance and identify improvements in the manufacturing process.
• Perform automation computer system support activities (e.g., system backups, performance monitoring, password maintenance).

Requirements

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