CSV Validation Specialist

3 days ago

Waterford, Waterford, Ireland beBeeValidation Full time €70,000 - €90,000

The role of CSV Engineer is crucial in ensuring the ongoing validation compliance of computerized equipment and systems in a sterile manufacturing environment.

Job Description

Catalyx seeks an experienced professional to play a key role in our team. The CSV Engineer will be responsible for leading and supporting validation activities for new and existing computerized equipment and control systems.

This includes generating validation documentation and assisting with the execution of validation protocols, participating in the change control process, advising on CSV matters, contributing to the development and execution of DQ, IQ, OQ, and PQ protocols, and ensuring all projects are delivered in line with cGMP, Health & Safety, environmental, and regulatory standards.

Required Skills and Qualifications

To excel in this role, you must possess a degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical), with post-graduate qualification desirable.

You should have 3–5 years' experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector, and 2–3 years' experience in a validation or CSV role.

Strong technical knowledge of pharmaceutical operations, project management experience, familiarity with GAMP, ISPE Baseline Guides, and quality/compliance regulations, as well as effective communication and facilitation skills, with ability to influence and work across multifunctional teams, are essential.

A highly motivated, adaptable, and pragmatic problem solver, you will thrive in a fast-paced environment where attention to detail and organizational skills are paramount.

Benefits

We offer a comprehensive Total Rewards package, including great professional growth opportunities, a diverse and inclusive workplace where all individuals are valued, respected, and supported, and assistance with Critical Skills Visa applications for eligible candidates.

Why Work with Us?

At Catalyx, we understand that our people are our greatest asset, and we take care of them. We strive to create a welcoming environment for everyone, committed to attracting the best global talent and supporting our international employees.

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