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