Validation Engineer

2 weeks ago

Waterford, Waterford, Ireland Recruitment By Aphex Group Full time
Were seeking a Validation Engineer to support a high-impact project with our Global Biologics client, ensuring compliance and validation of cutting-edge equipment, systems, and processes in a c GMP environment.

This is a fantastic opportunity to work with a global leader in pharmaceuticals and contribute to critical validation lifecycle activities.

Key Responsibilities: ? Execute and document FAT/SAT/IOQ protocols.

? Design and manage validation studies for equipment/processes (aseptic processing, lyophilisation, sterilisation, etc.).

? Ensure adherence to FDA/EU regulations, GAMP, ISPE, and AAMI/ANSI standards.

? Maintain validation documentation and support Site Change Control.

? Troubleshoot validation issues and collaborate cross-functionally.

Ideal Candidate: ?Education: Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical/Mechanical/Electrical).

?Experience: 3-5 years in healthcare/pharma manufacturing, with validation/product development expertise.

?Technical Skills: Knowledge of steam/dry heat validation, GMP, and quality management systems.

Familiarity with pack lines, autoclaves, or fill lines is a plus.

?Soft Skills: Adaptable, pragmatic problem-solver with strong communication and project management skills.

Skills: Document Execution Validation Studies Steam/Dry Heat Validation GMP Autoclaves Filling Lines

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