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Validation Engineer

On-site Full-time

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Experience Level

Experience

Qualifications

Qualifications:Bachelor's degree in Engineering, Life Sciences, or a related field. Experience in validation within a GMP environment is preferred. Strong understanding of validation principles and methodologies. Excellent communication skills, both written and verbal. Ability to work effectively in a team-oriented environment. Detail-oriented with strong analytical and problem-solving skills.

About the job

Catalyx is on the lookout for a skilled Validation Engineer to become a vital part of our team at our customer site in Cork.


About Us:

Catalyx is a pioneering machine vision and automation company dedicated to merging innovative technology with human expertise to empower global manufacturers and logistics firms to attain cutting-edge standards in quality and efficiency. With over three decades of experience, the creators behind Catalyx have continuously refined operational processes in highly regulated sectors through the invention of new technology applications and the provision of expert technical support. Our global presence spans 9 offices, with a workforce of over 550 professionals and more than 3,000 successful projects completed. We possess the expertise and reach to tackle unique process challenges on a large scale and are committed to pursuing what has never been achieved before. For more details, visit www.catalyx.ai.


The Opportunity:

As a Validation Engineer, you will play an integral role in supporting commissioning, qualification, and validation activities within a GMP-compliant manufacturing environment. Reporting to the CQV Manager, you will collaborate closely with cross-functional teams to ensure that systems, utilities, laboratory equipment, and manufacturing processes remain compliant and validated throughout their operational lifecycle.

Your responsibilities will include maintaining existing validated systems and assisting in the implementation of new systems and process enhancements within both manufacturing and laboratory settings.


Your Responsibilities:

  • Assist in validation activities across facilities, utilities, equipment, and analytical systems within a GMP-regulated manufacturing context.

  • Participate in the planning and execution of qualification tasks, including FUE Qualification, Computerized System Validation (CSV), and validation support for New Product Introductions and change initiatives.

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

  • Ensure compliance of validated systems and equipment, maintaining alignment with regulatory standards and site protocols.

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

  • Draft, review, and aid in the approval of validation documents, such as protocols, reports, change controls, deviations, and CAPAs.

  • Collaborate with cross-functional teams, including Manufacturing, Process Development, Quality Control, Quality Assurance, and Regulatory Affairs, to coordinate validation activities.

About Catalyx

Catalyx stands at the forefront of machine vision and automation technology, blending innovative solutions with expert knowledge to enhance manufacturing and logistics operations worldwide. With a rich legacy of over 30 years, we excel in optimizing complex processes and delivering unparalleled value to our clients through advanced technology and skilled professionals.

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