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Engenheiro de Validação
Hikma PharmaceuticalsSpecialist, Validation conducting qualification and validation activities for pharmaceutical projects at Hikma. Collaborating across teams to ensure compliance and effective execution of validation processes.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- Direct contract with Hikma
- Life insurance
- Health insurance
- Annual Performance Bonus
- High career prospects
ATS Keywords
✓ Tailor your resumeApplicant 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