Job Description

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:

Catalyx is seeking a Validation Engineer to join our team supporting a leading pharmaceutical manufacturing site in Cork. The role will support a range of upcoming projects and ongoing validation activities within a fast-paced GMP-regulated environment.

The successful candidate will take ownership of validation activities from planning and protocol generation through execution, documentation and final approval, working closely with Engineering, Manufacturing, Quality and other site functions.

Responsibilities:

• Generate, execute and complete validation protocols and final packages across facilities, utilities and equipment (FUE), computerised systems, new product introductions and change controls.

• Develop validation plans for specific system implementation and project activities.

• Manage validation deliverables from initiation through to completion, coordinating inputs and approvals across relevant departments.

• Prepare and progress change controls, deviations, quality events and CAPAs through to closure.

• Lead and represent validation within cross-functional project meetings.

• Coordinate validation activities across Manufacturing, Engineering, Process Sciences, QC, QA and other site functions.

• Work closely with QA throughout the validation lifecycle, responding to queries and progressing documentation through approval.

• Support regulatory inspection and audit readiness activities where required.

• Ensure validation activities are completed in accordance with site procedures, GMP requirements and applicable regulatory standards.

• Proactively identify dependencies or issues impacting validation activities and coordinate with the relevant teams to resolve them.

Requirements:

• Previous hands-on validation experience within a GMP pharmaceutical or biopharmaceutical manufacturing environment.

• Experience working directly within a pharmaceutical manufacturing site and its quality systems is highly desirable.

• Demonstrated experience owning validation activities and deliverables through the full lifecycle.

• Experience authoring validation protocols and documentation, rather than solely executing pre-defined protocols.

• Practical experience with change controls, deviations, quality events and CAPAs.

• Experience working closely with QA, Engineering and Manufacturing teams within a regulated environment.

• Exposure to facilities, utilities and equipment qualification and/or computerised system validation.

• Previous involvement in regulatory inspections or partner audits would be advantageous.

• Comfortable independently coordinating activities across multiple departments and progressing validation work through to completion.

• Approximately 2–4+ years’ relevant industry experience.

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.