About the job
Core
Managing validation activities for pharmaceutical manufacturing processes, including VMP, process validation, cleaning validation, and facility/equipment qualification.
Role type
Validation Engineer (GxP)
Builds
Validated manufacturing processes, facilities, and equipment for pharmaceutical production
Domain
Pharmaceutical manufacturing / GxP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Note: In this context, it refers to physical validation of processes and equipment in a manufacturing setting, but strictly following the allowed list, 'physical/clinical work' is the closest fit for non-digital, non-research validation tasks involving physical systems, though 'product features' or 'infrastructure' might be semantically closer. However, the instruction says 'one of: ...'. Let's re-evaluate. The role validates processes and equipment. This is 'infrastructure' (validating the manufacturing infrastructure) or 'product features' (validating the process that makes the product). Given the heavy focus on VMP, Process Val, and Qualification, 'infrastructure' is the best fit among the options for validating the manufacturing environment/systems.
Required skills
VMP management, process validation, cleaning validation, facility/equipment qualification, URS/DQ/FAT review, vendor management, GxP system validation, CPV/PLI response
Preferred skills
FDA/EMA audit experience, fluent English communication
Technologies
GxP systems, validation software (implied by context of VMP/CSV)
Responsibilities
Manage Validation Master Plan (VMP), perform process and cleaning validation, execute facility and equipment qualification, review URS/DQ/FAT, manage third-party vendors, support CPV and PLI
Seniority
Mid-level (5-12 years experience)
