Quality Validation Engineer

FRESENIUS KABI Beni Khalled, Nabeul Publiée le 5 janvier 2024
Expirée

Détails de l'annonce

Référence

193677

Date de publication

5 janvier 2024

Type de contrat

CDI

Lieu de travail

Beni Khalled, Nabeul, Tunisie

Expérience requise

Entre 1 et 2 ans

Niveau d'études

Bac + 5

Disponibilité

Plein temps

Langues

Français Anglais

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FRESENIUS KABI

Secteur: santé / paramédical / optique

Taille: Entre 200 et 500 employés

Description de l'annonce

Validation Engineer is responsible for planning, developing, implementing, and monitoring company's validation master plan

Validation engineer is responsible for ensuring process and products meet company’s requirements; running tests; analyzing and documenting results 


Responsibilities:


-Lead validations (manufacturing processes, equipment) and qualifications

-Lead Validation of new products transfer

-Design testing protocols that produce analyzable data

-Establish performance and quality criteria

-Create and run quality tests based on appropriate protocols

-Evaluate manufacturing systems processes and equipment

-Present validation test results and recommend improvements

-Train staff on validation parameters, oversee validation team, and document processes

-Coordinate validation implementation with all concerned Department, and lead validation meetings

-Analyze test data to determine the causes of defects, failure, or flaws and facilitate corrective measures

-Perform risk assessments and ensure compliance with applicable standards

-Oversee changes and collaborate with operational team on projects

-Prepare and maintain testing equipment

-Keep and update activity logs

-Perform troubleshooting

-Measure production processes and parameters against applicable standards

-Participate in operating the Quality Management System (QMS), writing procedures and processes to support the QMS development

-Participate in audits

-Perform internal audits

-Ensure compliance with safety and quality standards

Qualification required

-Previous experience as a validation engineer or in a similar role

-Strong understanding of manufacturing processes and safety regulations

-Knowledge of statistical software analysis (e.g. MATLAB)

-Bachelor's degree in engineering or a related field of specialization

-Experience in equipment calibration, performance testing, and quality control.

-Experience in data analysis tools and project management

-Analytical and problem-solving abilities.

-Leadership, collaboration, and communication skills.

-Organizational and time management abilities.

-Ability to ensure compliance with industry regulations.

-Fluent in English



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