Purpose:

We’re 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 cGMP environment. This is a fantastic opportunity to work with a global leader in pharmaceuticals and contribute to critical validation lifecycle activities.

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.

Requirements

Degree in Science (Chemistry, Microbiology, Pharmacy) or Engineering (Chemical/Mechanical/Electrical).
3-5 years in healthcare/pharma manufacturing, with validation/product development expertise.
Knowledge of steam/dry heat validation, GMP, and quality management systems. Familiarity with pack lines, autoclaves, or fill lines is a plus.
Adaptable, pragmatic problem-solver with strong communication and project management skills.