CSV Engineer

Catalyx is seeking a CSV Engineer to join our team and work on our customer site in Cork.

Who We Are:

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.

The Role:

Catalyx is a trusted partner in delivering world-class lifecycle services to regulated and high-risk end markets. With a relentless commitment to innovation and excellence, we partner with life science and other highly regulated organisations, to empower them to enhance efficiency, and drive success.  As part of this commitment, we are continuously developing our on-site teams to support the advancement of customer operations.

This is a high-impact role requiring immediate engagement in qualification activities and close collaboration with Commissioning & Qualification (C&Q) and Automation teams.

Responsibilities:

• Lead and execute the full lifecycle of qualification activities for both process control and packaging serialisation systems.

• Develop and manage validation deliverables including URS, FS, DS, Risk Assessments, IQ/OQ/PQ protocols, and final reports.

• Ensure that validation activities comply with site procedures, GMP regulations, and industry best practices (GAMP 5, FDA 21 CFR Part 11).

• Provide subject matter expertise for equipment and automation-related validation issues, including deviation resolution and change control.

• Participate in FAT, SAT, commissioning, and system handover processes for Delta V and serialisation systems.

• Engage directly with project teams to ensure validation requirements are integrated into project planning and execution.

• Collaborate with cross-functional teams including QA, Engineering, Automation, and Capital Projects to align validation strategies.

• Support data integrity assessments and implement improvements where necessary.

• Attend on-site meetings weekly; provide remote documentation support during protocol drafting and review stages.

Requirements:

• Experience in equipment/system qualification or CSV roles in a GMP environment.

• Strong hands-on experience with DCS systems (qualification and/or configuration support).

• Previous exposure to Serialisation systems in packaging environments is highly desirable.

• Demonstrated ability to work independently and deliver in fast-paced, project-driven environments.

• Experience in authoring and executing qualification documents (URS, FS, DS, IQ, OQ, PQ).

• Excellent communication and stakeholder management skills.

• Ability to work on-site at least once per week; remote working offered during documentation phases.

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, colour, 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.