Catalyx is seeking a CSV Engineer to join our team and work for our newly established team who are based on our customer site in Waterford.

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 RD, 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.

REQUIREMENTS:

• Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical).
• Post-graduate qualification desirable.
• 3–5 years’ experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector.
• 2–3 years’ experience in a validation or CSV role.
• Project management experience.
• Strong technical knowledge of pharmaceutical operations.
• Familiarity with GAMP, ISPE Baseline Guides, and quality/compliance regulations.
• Strong troubleshooting skills in validation projects.
• Effective communication and facilitation skills, with ability to influence and work across multifunctional teams.
• Highly motivated, adaptable, and pragmatic problem solver.

THE ROLE:

The CSV Engineer will play a key role in ensuring the ongoing validation compliance of computerised equipment and systems in a sterile manufacturing environment.

RESPONSIBILITIES:

• Lead and support validation activities for new and existing computerised equipment and control systems.
• Generate validation documentation (protocols/reports) and assist with the execution of validation protocols.
• Participate in the change control process, advising on CSV matters.
• Contribute to the development and execution of DQ, IQ, OQ, and PQ protocols.
• Ensure all projects are delivered in line with cGMP, Health Safety, environmental, and regulatory standards.
• Design, implement, and execute validation studies for manufacturing and control systems, including critical utilities and facilities.
• Provide guidance on current US FDA and EU validation requirements for sterile processing, including aseptic techniques, lyophilisation, and sterilisation.
• Maintain validation documentation and ensure equipment and systems remain compliant with cGMP requirements.
• Support preparation, review, and approval of validation/revalidation plans and site change controls.