Ingénieur Validation

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