Validation Specialist
Core
Execute validation activities for facilities, equipment, and processes to ensure compliance with regulatory requirements (HPRA/FDA) and client expectations.
Role type
Validation Specialist (GMP/Regulated Environment)
Builds
Validated manufacturing processes, facilities, and computer systems for biopharma clients
Domain
Biopharmaceuticals / Quality Assurance / GMP
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Process Validation, Cleaning Validation, Computer Systems Validation, sampling (AQL), deviation investigation, change control management, regulatory compliance (HPRA/FDA), GMP environment experience, Microsoft Office proficiency
Preferred skills
Lean Manufacturing, continuous improvement tools
Technologies
Microsoft Office (Excel, PowerPoint, Word)
Responsibilities
Generate and review validation protocols and reports for facilities, equipment, and processes; execute validation activities with minimal supervision; perform sampling in support of validation studies; manage tooling validations and associated documentation; support complaint and deviation investigations; conduct periodic reviews and revalidations; ensure strict implementation of validation procedures and documentation accuracy.
Seniority
Mid-level, hands-on IC
