Hikma Pharmaceuticals

Engenheiro de Validação

Hikma Pharmaceuticals

full-time

Posted on:

Location Type: Office

Location: Sintra • Portugal

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About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
validation activitiesqualification protocolsvalidation reportsStandard Operating ProceduresValidation Master PlansFATsSATsrisk-based validationdata integrity principlesvalidation projects
Soft Skills
collaborationtrainingguidanceinvestigationcommunication
Certifications
Bachelor's degreedegree in Engineering