Validation and Calibration Engineer ensuring equipment reliability and product quality in a pharmaceutical environment. Planning, executing, and maintaining validation and calibration activities in compliance with cGMP regulations.
About the role
- Specialist, Validation conducting qualification and validation activities for pharmaceutical projects at Hikma. Collaborating across teams to ensure compliance and effective execution of validation processes.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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