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Validation Engineer at Catalyx | Cork

On-site Full-time

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Experience Level

Experience

Qualifications

The ideal candidate should possess a relevant degree in Engineering, Science, or a related field, with experience in validation within a GMP setting preferred. Familiarity with validation processes and regulatory requirements is essential. Strong analytical skills, excellent communication abilities, and the capacity to work collaboratively in a team-oriented environment are crucial.

About the job

Catalyx is actively searching for a dedicated Validation Engineer to become a key member of our team, working directly at our customer site in Cork.


About Us:

At Catalyx, we are a pioneering company in machine vision and automation, committed to merging technology and human expertise to elevate global manufacturing and logistics to unprecedented standards of quality and efficiency. With over three decades of experience, our team has been transforming operational processes across highly regulated sectors by innovating new technological applications and providing expert support. Operating from 9 global offices with a team of over 550 professionals, we have successfully executed more than 3,000 projects and continue to tackle unique challenges with a forward-thinking approach. Discover more about us at www.catalyx.ai.


Your Role:

As a Validation Engineer, you will play a vital role in supporting commissioning, qualification, and validation processes within a GMP-regulated manufacturing setting. Reporting to the CQV Manager, you will collaborate with cross-functional teams to ensure that all systems, utilities, laboratory equipment, and manufacturing processes are compliant and validated throughout their lifecycle.

This role requires the maintenance of existing validated systems and active involvement in the implementation of new systems and process enhancements across both manufacturing and laboratory environments.


Key Responsibilities:

  • Facilitate validation activities across utilities, equipment, analytical systems, and facilities in a GMP-regulated manufacturing environment.

  • Assist in planning and executing qualification activities, including FUE Qualification, Computerized System Validation (CSV), and validation for New Product Introductions and change initiatives.

  • Contribute to the creation and upkeep of Validation Master Plans, validation protocols, reports, and related documentation.

  • Ensure validation compliance for existing systems and equipment, maintaining alignment with regulatory standards and site procedures.

  • Support the qualification and validation of critical systems, including HVAC, temperature-controlled environments, cleaning and steaming systems, autoclaves, and associated process utilities.

  • Prepare, review, and facilitate the approval of validation documentation, including protocols, reports, change controls, deviations, and CAPAs.

  • Coordinate validation efforts with cross-functional teams including Manufacturing, Process Development, Quality Control, Quality Assurance, and Regulatory Affairs.

About Catalyx

Catalyx is at the forefront of machine vision and automation, committed to enhancing quality and efficiency for manufacturers and logistics providers worldwide. Our innovative approach and technical expertise enable us to address complex operational challenges and set new standards in various industries.

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