# Ingénieur Validation - **Entreprise** : [IBN AL BAYTAR HIKMA](https://www.keejob.com/offres-emploi/entreprises/9622/ibn-al-baytar/) - **Lieu** : Ariana Ville, Ariana, Tunisie - **Type de contrat** : CDI - **Niveau d'études** : Bac + 5 - **Expérience** : Entre 2 et 5 ans - **Langues** : Français, Anglais - **Métiers** : Ingénieur Chimiste - **Date de publication** : 2026-09-22 - **Date d'expiration** : 2026-10-22 - **Référence Keejob** : 247445 - **Statut** : Offre active ## Description ### Location: Sidi Thabet Job Type: CDI About Us For over 45 years, Hikma Pharmaceuticals has been putting better health within reach, every day, by creating high-quality medicines and making them accessible to those who need them. We are helping to shape a healthier world that enriches all our communities, and our global team of 9,500+ empowered employees are central to this mission. As a trusted and reliable partner of over 800 high-quality generics, specialty and branded pharmaceutical products, we are driven to improve access to medicine. Through our 29 manufacturing plants, 9 R&D centers across the MENA, North America and Europe, our footprint allows us to play a critical role in serving patients.  Description: We are looking for a talented Validation Engineer to join us. At Hikma you’ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We’re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together. ### Key Responsibilities * Develop, review, and execute validation protocols and reports, including: * Installation Qualification (IQ) * Operational Qualification (OQ) * Performance Qualification (PQ) * Lead validation activities for manufacturing equipment, utilities, facilities, and production processes. * Support cleaning validation, process validation, and computerized system validation (CSV) projects. * Ensure compliance with GMP, FDA, EMA, WHO, and other applicable regulatory requirements. * Conduct risk assessments and validation impact assessments related to changes, deviations, and CAPA activities. * Review technical documentation, standard operating procedures (SOPs), and validation master plans (VMPs). * Collaborate with Quality Assurance, Engineering, Production, and Regulatory Affairs teams. * Participate in internal audits, regulatory inspections, and customer audits. * Monitor the validated state of systems and recommend improvements to validation processes. ### Qualifications & Experience #### Required * Bachelor's degree in Engineering, Pharmaceutical Sciences, Biotechnology, Chemistry, or a related discipline. * Minimum **3–5 years of experience** in validation within a pharmaceutical, biotechnology, or medical device environment. * Strong knowledge of GMP regulations and validation lifecycle principles. * Experience with qualification of manufacturing equipment and utilities. * Familiarity with FDA 21 CFR Part 11, GAMP 5, Annex 11, and data integrity requirements. * Strong analytical, problem-solving, and documentation skills. * Excellent communication skills and ability to work in cross-functional teams. * Proficiency in Microsoft Office applications. #### Preferred * Experience with sterile manufacturing, aseptic processing, or cleanroom environments. * Knowledge of process validation, cleaning validation, and computerized system validation. * Certification in validation, quality, or pharmaceutical engineering is an advantage. ### Key Competencies * Attention to detail * Regulatory compliance mindset * Project management skills * Technical writing and reporting * Continuous improvement orientation * Teamwork and collaboration ## Postuler Postulez directement sur Keejob : https://www.keejob.com/offres-emploi/247445/ing%C3%A9nieur-validation/ --- Source : Keejob.com, le site de l'emploi en Tunisie.