Automation SME

Catalyx is seeking an Automation Subject Matter Expert (SME) provides technical leadership for the design, implementation, validation, and lifecycle support of automation systems supporting biologics manufacturing operations. This role ensures automation solutions are reliable, compliant, secure, and aligned with industry standards while supporting upstream and downstream process performance. The SME works closely with engineering, manufacturing, quality, validation, and system integration teams to deliver scalable automation solutions throughout the project lifecycle.

Responsibilities

·       Provide technical leadership for automation systems supporting biologics manufacturing, including upstream, downstream, buffer/media preparation, and clean utility systems.

·       Develop and review automation architecture, control strategies, functional specifications, batch recipes, and system design documentation.

·       Support automation deployment strategies, technology evaluations, and digital manufacturing initiatives, including data integration and operational optimization.

·       Oversee system integration, commissioning, qualification, and validation activities, including FAT, SAT, IQ/OQ, and commissioning support.

·       Ensure automation systems comply with GMP, GAMP 5, ISA-88, ISA-95, data integrity, cybersecurity, and other applicable regulatory standards.

·       Collaborate with cross-functional teams to define process control requirements, batch reporting, system interfaces, and operational readiness.

·       Support risk assessments, alarm management, cybersecurity, and automation lifecycle management.

·       Provide technical guidance to vendors, system integrators, and internal engineering teams while promoting automation best practices and continuous improvement.

Requirements

·       Bachelor''s or Master''s degree in Automation, Electrical, Controls, Chemical, Process Engineering, or a related technical discipline.

·       8+ years of experience supporting automation systems in GMP biologics or pharmaceutical manufacturing environments.

·       Strong experience with DCS, PLC, SCADA, ISA-88 batch systems, process historians, MES/LIMS integration, and industrial networking.

·       Hands-on experience with biologics manufacturing processes, including bioreactors, chromatography, UF/DF, filtration, CIP/SIP, and clean utilities.

·       Working knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, computerized system validation (CSV), and data integrity principles.

·       Experience leading automation system design, commissioning, qualification, troubleshooting, and lifecycle support.

·       Excellent communication, technical leadership, and cross-functional collaboration skills.

·       Preferred certifications include ISA CAP, GAMP, Functional Safety, or relevant automation platform certifications.