Automation SME

Xyntek Inc.; Gaithersburg (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Catalyx is seeking an Automation Subject Matter Expert (SME) to provide technical leadership for the design, implementation, validation, and lifecycle support of automation systems in biologics manufacturing. This role collaborates with engineering, manufacturing, quality, validation, and systems integration teams to deliver scalable automation solutions throughout the project lifecycle.

You will ensure systems are reliable, compliant, and aligned with industry standards, while supporting

Qualifications

• Bachelor's or Master's degree in Automation, Electrical, Controls, Chemical, Process Engineering, or related discipline.
• 8+ years of experience supporting automation systems in GMP biologics/pharmaceutical manufacturing.
• Experience with DCS, PLC, SCADA, ISA-88/ISA-95, MES/LIMS integration, and industrial networking.
• Hands-on with biologics processes (bioreactors, chromatography, UF/DF, CIP/SIP, clean utilities).
• Knowledge of GMP, GAMP 5, ISA-88, ISA-95, ISA/IEC 62443, ALCOA+, CSV, and data integrity.

Responsibilities

• Provide technical leadership for automation systems in biologics manufacturing.
• Develop and review automation architecture, control strategies, batch recipes, and design docs.
• Support deployment strategies, technology evaluations, and digital manufacturing initiatives.
• Oversee commissioning, qualification, and validation activities (FAT, SAT, IQ/OQ).
• Ensure compliance with GMP, GAMP 5, ISA-88/95, data integrity, and cybersecurity.
• Collaborate with cross-functional teams to define process control requirements and interfaces.
• Support risk assessments, alarm management, lifecycle management, and vendor guidance.
• Promote automation best practices and continuous improvement.

Skills

Automation

Control systems

GMP

Biologics

DCS/PLC/SCADA

ISA-88/ISA-95

MES/LIMS

Cybersecurity

Validation

Collaboration

Education

Bachelor's or Master's degree in Automation/Electrical/Controls/Chemical/Process Engineering

Tools

DCS

PLC

SCADA

ISA-88

MES/LIMS

Job description

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 VistaLink) 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 www.catalyx.ai .

Job Description

Catalyxis seeking an Automation Subject Matter Expert (SME) provides technicalleadership for the design, implementation, validation, and lifecycle support ofautomation systems supporting biologics manufacturing operations. This roleensures automation solutions are reliable, compliant, secure, and aligned withindustry standards while supporting upstream and downstream processperformance. The SME works closely with engineering, manufacturing, quality,validation, and system integration teams to deliver scalable automation solutionsthroughout the project lifecycle.

Responsibilities

• 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, anddigital manufacturing initiatives, including data integration and operationaloptimization.
• Oversee system integration, commissioning, qualification, and validationactivities, including FAT, SAT, IQ/OQ, and commissioning support.
• Ensure automation systems comply with GMP, GAMP 5, ISA-88, ISA-95, dataintegrity, cybersecurity, and other applicable regulatory standards.
• Collaborate with cross-functional teams to define process controlrequirements, batch reporting, system interfaces, and operational readiness.
• Support risk assessments, alarm management, cybersecurity, andautomation lifecycle management.
• Provide technical guidance to vendors, system integrators, and internalengineering teams while promoting automation best practices and continuousimprovement.

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 orpharmaceutical manufacturing environments.
• Strong experience with DCS, PLC, SCADA, ISA-88 batch systems, processhistorians, MES/LIMS integration, and industrial networking.
• Hands-on experience with biologics manufacturing processes, includingbioreactors, 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-functionalcollaboration skills.
• Preferred certifications include ISA CAP, GAMP, Functional Safety, orrelevant automation platform certifications.

Why Join Catalyx?

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

Catalyx is an Equal Opportunity Employer. We are committedto 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 applicationsfrom all qualified candidates, regardless of background, and strive to create awelcoming environment for everyone.

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