Were seeking aValidation 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 cGMP 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