Automation SME

Gaithersburg, United States | Posted on 08/03/2026

Catalyx specializes in the science of operational processes. With a footprint across North America and Europe, the company carefully automates and services R&D, production, packaging, and delivery processes—globally—with a sophisticated blend of products, technologies, and lifecycle services. The company was formed in 2022 after CXV Global (Crest Solutions, Xyntek, and Vista Link) and Panacea Technologies joined forces. For over three decades, Catalyx’s partnership-based culture has helped organizations in production-intense, highly regulated industries optimize their operational efficiency, performance, and safety.

To learn more about the company's experience and comprehensive suite of capabilities and solutions, visit (Use the "Apply for this Job" box below). .

Catalyxis 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.

• Provide technical leadership for automation systems supporting biologics manufacturing, including upstream, downstream, buffer/media preparation, andclean 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.

• 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.

At Catalyx we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Catalyx benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities.

Catalyx is an Equal Opportunity Employer. We are committed to creating a diverse and inclusive workplace where all individuals are valued,respected, and supported. We do not discriminate on the basis of race, color,religion, sex (including pregnancy, gender identity, and sexual orientation),national origin, age, disability, veteran status, genetic information, or anyother characteristic protected by applicable law. We encourage applications from all qualified candidates, regardless of background, and strive to create awelcoming environment for everyone.

At Catalyx, we are committed to attracting the best global talent. We proudly support our international employees by offering assistance with Critical Skills Visa applications for eligible candidates.