Lead Automation Engineer

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.

Key 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

·       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

Preferred Experience

·       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

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.