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

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

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.