Job Title:
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.
About Catalyx:
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 joining forces with CXV Global (Crest Solutions, Xyntek, and VistaLink) and Panacea Technologies.
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 our website.
The Role:
* 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.
Requirements:
A degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical). A post-graduate qualification is desirable. Experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector, is required. The candidate must have at least 2–3 years' experience in a validation or CSV role and good project management skills. Strong technical knowledge of pharmaceutical operations is essential.
Why Join Us?
We understand that our people are our greatest asset. For this reason and many others, we take care of them. Our total rewards package includes great professional growth opportunities. We are an Equal Opportunity Employer and committed to creating a diverse and inclusive workplace where all individuals are valued, respected, and supported.