Lead Automation Engineer

Catalyx • Bradley, IL

5d

About The Position

Catalyx is seeking an experienced Automation Area Lead to provide technical leadership for a defined process area within a pharmaceutical capital project. This role is responsible for oversight of the full automation stack (Levels 0–4), including process control systems, batch automation (S88), MES, and integration with enterprise systems. The individual will support design reviews, vendor coordination, and system integration activities to ensure alignment with project standards, regulatory expectations, and operational objectives.

Requirements

• Strong technical expertise in pharmaceutical automation systems and process controls
• Experience with Siemens DCS platforms, OpCenter MES, and integrated manufacturing systems
• Knowledge of ISA-88 batch control principles, GAMP 5, and GxP-regulated environments
• Proven experience supporting pharmaceutical or biotech capital projects
• Experience managing multiple vendors and working within EPC or multi-contractor project environments
• Strong communication, leadership, and stakeholder management skills
• Ability to work effectively in cross-functional and fast-paced project teams

Nice To Haves

• Experience supporting commissioning, qualification, and validation activities in regulated manufacturing environments
• Familiarity with integration between process automation, MES, historians, and enterprise systems
• Demonstrated ability to lead technical discussions and drive decision-making across project teams

Responsibilities

• Provide oversight of automation system design and architecture across Siemens DCS, OpCenter MES, and interfaces to package units and Level 3/Level 4 systems
• Ensure compliance with ISA-88, GAMP 5, and GxP requirements
• Lead and participate in design reviews including URS, Functional Specifications, and Design Specifications
• Promote standardization, modular design principles, and scalable automation solutions
• Drive risk management activities including GxP assessments and system risk assessments
• Coordinate and manage system integrators, OEMs, and automation vendors
• Support project execution through all phases including design, FAT/SAT, commissioning, qualification, and validation
• Collaborate with cross-functional engineering, manufacturing, validation, and quality teams to ensure successful project delivery
• Identify technical risks, recommend mitigation strategies, and support issue resolution throughout the project lifecycle

Benefits

• Total Rewards package
• Great personal benefits
• Professional growth opportunities
• Assistance with Critical Skills Visa applications for eligible candidates

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed