Field of expertise

Quality

Job description

experienced Validation Engineer to support the qualification and validation of laboratory equipment used in the development and manufacturing products within a pharmaceutical manufacturing environment;
lead and execute qualification and validation activities for 4–5 laboratory instruments, including spectrophotometers and other analytical devices;
develop technical specifications and User Requirement Specifications (URS) for laboratory equipment;
prepare and execute qualification documentation, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification), as applicable;
define technical, functional, and safety requirements for laboratory equipment;
assess the technical integration, functionality, and compatibility of equipment components;
ensure equipment compliance with applicable safety standards, quality requirements, and GMP principles (Group Manufacturing Practice);
develop and maintain complete validation documentation, including protocols, test reports, deviations, and final validation reports;
identify and resolve technical issues during equipment qualification and validation;
collaborate with laboratory, engineering, quality assurance, and manufacturing teams;
ensure that all validated equipment is ready for routine use and supports the transition to commercial-scale production.