Catalyx is seeking a Validation 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:
The Validation Engineer will support commissioning, qualification, and validation activities within a GMP‑regulated manufacturing facility. Reporting to the CQV Manager, the successful candidate will work closely with cross‑functional teams to ensure systems, utilities, laboratory equipment, and manufacturing processes remain compliant and validated throughout their lifecycle.
This position will involve maintaining existing validated systems as well as supporting new system implementations and process improvements across manufacturing and laboratory environments.
Responsibilities:
Support validation activities across facilities, utilities, equipment, and analytical systems in a GMP‑regulated manufacturing environment.
Assist in the planning and execution of qualification activities including FUE Qualification, CSV, and validation support for New Product Introductions and change initiatives.
Contribute to the development and maintenance of Validation Master Plans, validation protocols, reports, and supporting documentation.
Maintain validation compliance for existing systems and equipment, ensuring continued alignment with regulatory requirements and site procedures.
Support qualification and validation of critical systems including HVAC, temperature‑controlled environments, cleaning and steaming systems, autoclaves, and associated process utilities.
Prepare, review, and support approval of validation documentation including protocols, reports, change controls, deviations, and CAPAs.
Coordinate validation activities with cross‑functional teams including Manufacturing, Process Development, Quality Control, Quality Assurance, and Regulatory Affairs.
Participate in project and technical review meetings, representing validation and ensuring alignment with validation strategy and compliance requirements.
Support regulatory inspections and partner audits through preparation of documentation and participation in audit discussions where required.
Identify and implement improvements to validation systems, procedures, and documentation practices.
Maintain awareness of current regulatory expectations and industry best practices relating to validation and qualification within the life sciences sector.
Requirements:
Bachelor’s degree in Engineering, Science, or a related technical discipline.
Approximately 2–4 years’ experience working in a pharmaceutical, biotechnology, or other GMP‑regulated manufacturing environment.
Exposure to validation of systems such as HVAC, temperature‑controlled systems, cleaning systems, autoclaves, or related process utilities would be advantageous.
Strong documentation skills with experience preparing and reviewing validation protocols and reports.
Ability to collaborate effectively with cross‑functional teams within a regulated manufacturing environment.
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.
#J-18808-Ljbffr