Engenheiro de Validação

Role Overview

• Plans and executes qualification and validation activities for equipment, utilities, facilities, and processes
• Plans the scheduling, preparation, execution, and documentation of validation activities
• Plans and executes documentation of internal and external validation field activities
• Issues the drafting of documentation of qualification and validation protocols and reports
• Issues the drafting and revision of department‑applicable Standard Operating Procedures (SOPs)
• Support the verification of conformance of activities performed by external validation contractors
• Support the maintenance of Validation Master Plans (VMPs)
• Plans the coordination and execution with external suppliers and manufacturers for FATs, SATs, and qualification activities
• Plans and executes validation activities for sterile injectables at the Portugal site
• Collaborate with cross‑functional teams (Quality Unit, Manufacturing, Engineering, Maintenance)
• Plans and supports the training and day‑to‑day guidance of junior validation personnel
• Issues and supports investigations of validation-related deviations
• Support tracking of agreed CAPAs and effectiveness checks to closure
• Maintain up‑to‑date knowledge of GxP requirements, validation best practices, and applicable regulatory expectations
• Ensure adherence to global and local standards in the execution of validation activities
• Support internal and external audits

Requirements

• Bachelor's degree or equivalent in technical/science (Minimum)
• Degree in Engineering in Mechanical, Electro technical or Chemistry (Preferred)
• Demonstrated experience in validation projects
• Demonstrated computer skills including Word, Excel and CAD
• English Intermediate Level
• Knowledge of risk-based validation approaches and data integrity principles
• Familiarity with electronic validation documentation systems

Benefits

• Direct contract with Hikma
• Life insurance
• Health insurance
• Annual Performance Bonus
• High career prospects