CSV Engineer

Catalyx; Cork; Hybrid; EUR 60.000 - 75.000; Vollzeit

Zusammenfassung

Catalyx is seeking a CSV Engineer to join our team on a major pharmaceutical project in Cork. The role focuses on laboratory IT systems, validation, documentation, and cross-functional project support within a GMP-regulated environment.

You will collaborate with QC, IT, engineering and project teams to ensure systems stay compliant, reliable and aligned with regulatory and data integrity requirements. Hybrid position across site activities.

Qualifikationen

• Degree in IT, Computer Science, BIS, Chemistry, Biology or related discipline.
• Experience with GMP or regulated laboratory environments is advantageous.
• Strong troubleshooting and problem-solving skills.
• Excellent communication and stakeholder management.
• Ability to work independently and within cross-functional teams.

Aufgaben

• Support delivery of laboratory systems projects within a GMP-regulated QC environment.
• Collaborate with site teams on system requirements, configurations and IOQ documentation.
• Author, review and approve validation and lifecycle documentation for laboratory systems.
• Assist with risk assessments related to laboratory systems and processes.
• Support deployment, configuration and end-user training for QC lab IT systems.
• Troubleshoot and maintain reliability of QC laboratory IT systems.
• Work cross-functionally with QC, IT, engineering, validation and project stakeholders.
• Ensure GMP, data integrity and regulatory compliance including 21 CFR Part 11.
• Contribute to continuous improvement within the laboratory systems environment.
• Maintain strong documentation practices and high compliance standards.

Kenntnisse

Communication

Problem solving

Independent working

Cross-functional collaboration

Ausbildung

Degree in IT, Computer Science, BIS, Chemistry, Biology or related discipline

Tools

Windows 10/11

Server environments

CSV

Jobbeschreibung

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

Who We Are:

Catalyx is a machine vision and automation company that integrates technology and people to help global manufacturers and logistics companies achieve next-generation levels of quality and throughput. For over thirty years, the minds behind Catalyx have been at work maximizing operational processes across highly regulated industries by inventing new technology applications and supporting companies with technical experts. With 9 global offices, over 550 team members, and 3,000 projects under our belt (and counting), we have the capabilities and reach to solve unique process problems at scale – and the vision to keep doing what’s never been done before. For more information visit www.catalyx.ai.

The Role:

Catalyx is seeking a CSV Engineer to join a major pharmaceutical project supporting laboratory systems and quality control operations in a GMP-regulated environment.

This role will support both ongoing and new laboratory projects, with a strong focus on laboratory IT systems, system validation, documentation, and cross-functional project support. The successful candidate will work closely with QC, IT, engineering, and project teams to ensure laboratory systems remain compliant, reliable, and aligned with regulatory and data integrity requirements.

This is a hybrid position with involvement in a range of laboratory systems and digital transformation activities across the site.

Responsibilities:

• Support the delivery of laboratory systems projects within a GMP-regulated QC environment.
• Work closely with site teams on system requirements gathering, configuration specifications, and IOQ protocol generation.
• Author, review, and approve validation and lifecycle documentation for laboratory systems.
• Support risk assessments related to laboratory systems and associated processes.
• Assist with deployment activities, system configuration, and end-user support/training.
• Support troubleshooting and ongoing reliability of QC laboratory IT systems.
• Collaborate cross-functionally with QC, IT, engineering, validation, and project stakeholders.
• Ensure compliance with GMP, data integrity, and regulatory requirements including 21 CFR Part 11 principles.
• Support ongoing continuous improvement activities within the laboratory systems environment.
• Maintain strong documentation practices and ensure work is completed to a high compliance standard.

Requirements:

• Degree qualification in IT, Computer Science, Business Information Systems, Chemistry, Biology, or a related discipline.
• Experience supporting laboratory or GMP systems within a pharmaceutical or regulated environment is advantageous.
• Strong knowledge of Microsoft Windows operating systems including Windows 10/11 and server-based environments.
• Experience with CSV, system lifecycle documentation, or qualification activities would be beneficial.
• Understanding of GMP environments, data integrity, and regulatory compliance principles.
• Strong troubleshooting and problem solving skills.
• Excellent communication and stakeholder management skills.
• Ability to work both independently and within cross-functional project teams.
• Strong organisational skills with the ability to manage multiple priorities simultaneously.
• Experience supporting QC laboratory operations or laboratory applications is desirable.

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.