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.

Why Join Catalyx?

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 any
other characteristic protected by applicable law. We encourage applications
from all qualified candidates, regardless of background, and strive to create a
welcoming 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.